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Background/Purpose: The usefulness of endoscopic biliary stenting by deploying a plastic stent suprapapillary, called inside‐stent (IS) placement, as preoperative biliary drainage (PBD) for perihilar biliary malignancy (PHBM) has been demonstrated. This study investigated risk factors for recurrent biliary obstruction (RBO) after IS placement. Methods: Consecutive patients with potentially resectable PHBM treated with IS placement as PBD between 2017 and 2023 at Nagoya University Hospital were retrospectively reviewed. Results: A total of 157 patients were included, with RBO occurring in 34 (22%) patients. The non‐RBO rates were 83% at 30 days, 77% at 60 days, and 57% at 90 days. The most common cause of RBO was stent occlusion (n = 14), followed by segmental cholangitis (n = 12) and stent migration (n = 8). Stent migration and occlusion occurred more frequently within and after 1 week post‐stenting, respectively. In multivariate analysis, biliary infection before IS was the sole risk factor for RBO, with a hazard ratio of 2.404 (95% confidence interval 1.163–4.972; p =.018). This risk was reduced by temporary endoscopic nasobiliary drainage prior to definitive IS placement. Conclusions: Biliary infection before IS was identified as an independent risk factor for RBO in patients with PHBM with IS as PBD. Clinical Trial Register: Clinical trial registration number: UMIN000025631. [ABSTRACT FROM AUTHOR]

Background and Aim: The 10‐mm self‐expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10 mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6‐mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer. Methods: This was a single‐arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent‐related adverse events, and the key secondary endpoint was the non‐recurrent biliary obstruction (non‐RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers. Results: The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent‐related adverse event rate was 3.1% (n = 1, acute pancreatitis) (95% confidential interval, 0.00–16.2), which met the criteria to be considered safe. The overall non‐RBO rate during the observation period (median 96 days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively). Conclusions: The 6‐mm FCSEMS is an extremely safe metallic stent with a low stent‐related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non‐RBO rate. UMIN Clinical Trial Registry (UMIN‐CTR 000041704). [ABSTRACT FROM AUTHOR]

Abstract Background/Purpose Endoscopic biliary stenting (EBS) is commonly used for preoperative drainage of localized perihilar cholangiocarcinoma (LPHC). This study retrospectively compared the utility of inside stent (IS) and conventional stent (CS) for preoperative EBS in patients with LPHC. Methods EBS was performed in 56 patients with LPHC. EBS involved the placement of a CS (n = 32) or IS (n = 24). Treatment outcomes were compared between these two groups. Results Preoperative recurrent biliary obstruction (RBO) occurred in 23 patients (71.9%) in the CS group and 7 (29.2%) in the IS group, with a significant difference (p = 0.002). The time to RBO (TRBO) was significantly longer in IS than in CS (log-rank: p

Objectives: For preoperative biliary drainage (PBD) of malignant hilar biliary obstruction (MHBO), current guidelines recommend endoscopic nasobiliary drainage (ENBD) due to the higher risk of cholangitis after endoscopic biliary stenting (EBS) during the waiting period before surgery. However, few studies have supported this finding. Therefore, we aimed to compare the outcomes of preoperative ENBD and EBS in patients with MHBO. Methods: Patients with MHBO who underwent laparotomy for radical surgery after ENBD or EBS were included from retrospectively collected data from 13 centers (January 2014 to December 2018). We performed a 1:1 propensity score matching between the ENBD and EBS groups. These patients were compared for the following: cholangitis and all adverse events (AEs) after endoscopic biliary drainage (EBD) until surgery, time to cholangitis development after EBD, postsurgical AEs, and in‐hospital death after surgery. Results: Of the 414 patients identified, 355 were analyzed in this study (226 for ENBD and 129 for EBS). The matched cohort included 63 patients from each group. The proportion of cholangitis after EBD was similar between the two groups (20.6% vs. 25.4%, P = 0.67), and no significant difference was observed in the time to cholangitis development. The proportions of surgical site infections, bile leaks, and in‐hospital mortality rates were similar between the groups. Conclusion: For PBD of MHBO, the proportion of AEs, including cholangitis, after EBD until surgery was similar when either ENBD or EBS was used. [ABSTRACT FROM AUTHOR]

Background/Purpose: Endoscopic biliary stenting (EBS) is commonly used for preoperative drainage of localized perihilar cholangiocarcinoma (LPHC). This study retrospectively compared the utility of inside stent (IS) and conventional stent (CS) for preoperative EBS in patients with LPHC. Methods: EBS was performed in 56 patients with LPHC. EBS involved the placement of a CS (n = 32) or IS (n = 24). Treatment outcomes were compared between these two groups. Results: Preoperative recurrent biliary obstruction (RBO) occurred in 23 patients (71.9%) in the CS group and 7 (29.2%) in the IS group, with a significant difference (p = 0.002). The time to RBO (TRBO) was significantly longer in IS than in CS (log-rank: p < 0.001). The number of stent replacements was significantly lower in IS than CS [0.38 (0–3) vs. 1.88 (0–8), respectively; p < 0.001]. Gemcitabine-based neoadjuvant chemotherapy (NAC) was administered to 26 patients (46.4%). Among patients who received NAC, TRBO was longer in IS than in CS group (log-rank: p < 0.001). The IS group had a significantly shorter preoperative and postoperative hospital stay than the CS group (20.0 vs. 37.0 days; p = 0.024, and 33.5 vs. 41.5 days; p = 0.016). Both the preoperative and the postoperative costs were significantly lower in the IS group than in the CS group (p = 0.049 and p = 0.0034, respectively). Conclusion: Compared with CS, IS for preoperative EBS in LPHC patients resulted in fewer complications and lower re-intervention rates. The fact that the IS group had shorter preoperative and postoperative hospital stays and lower costs both preoperatively and postoperatively compared to the CS group may suggest that the use of IS has the potential to benefit not only the patient but also the healthcare system. [ABSTRACT FROM AUTHOR]

Background: Pancreatic head cancer accompanied by obstructive jaundice is a common clinical situation. The aim of this study was to assess the impact of preoperative biliary drainage (PBD) on clinical outcomes in patients with severe obstructive jaundice. Methods: Patients with a bilirubin level of ≥250 µmol/L at diagnosis who underwent PBD were included. The primary endpoints and secondary endpoints were the postoperative severe complications rates. Secondary endpoints were the degree of improvement in general condition, predictors of severe postoperative complications, and the impact of PBD on patients with bilirubin levels >300 µmol/L. Results: In total, 289 patients were included, and 188 patients (65.1%) underwent PBD. The patients who met the American Society of Anesthesiologists (ASA) classification II-III stages decreased from 119 to 100 (P = 0.047) after PBD. The overall severe complications were significantly more frequent in the direct surgery (DS) group than in the PBD group (34.7% vs. 22.9%, P = 0.031), especially the postoperative hemorrhage (6/43 [14.0%] vs. 9/35 [25.7%], P = 0.038) and intra-abdominal infection (6/43 [14.0%] vs. 10/35 [28.6%], P = 0.018). The ASA classifications II--III (odds ratio [OR]=2.89, 95% confidence interval [CI]: 1.38-4.31), P = 0.01) and DS (OR = 3.65, 95% CI: 1.45-7.08; P = 0.003) were independently associated with severe postoperative complications. The occurrence rate of severe postoperative complications in patients with a bilirubin level >300 µmol/L who underwent PBD was significantly lower than in patients who underwent DS (25.6% vs. 40.6%, P = 0.028), but the benefit of PBD was not observed in patients who had a bilirubin level between 250 and 300 µmol/L. Conclusion: PBD is useful in reducing severe postoperative complications, especially in patients with bilirubin levels >300 µmol/L. [ABSTRACT FROM AUTHOR]

Background: For patients with hilar cholangiocarcinoma (HC) undergoing hemihepatectomy, there are controversies regarding the requirement of, indications for, and timing of preoperative biliary drainage (PBD). Dynamic threedimensional volume reconstruction could effectively evaluate the regeneration of liver after surgery, which may provide assistance for exploring indications for PBD and optimal preoperative bilirubin value. The purpose of this study was to explore the indications for PBD and the optimal preoperative bilirubin value to improve prognosis for HC patients undergoing hemi-hepatectomy. Methods: We retrospectively analyzed the data of HC patients who underwent hemi-hepatectomy in the First Affiliated Hospital of China Medical University from 2012 to 2023. The liver regeneration rate was calculated using threedimensional volume reconstruction. We analyzed the factors affecting the liver regeneration rate and occurrence of postoperative liver insufficiency. Results: This study involved 83 patients with HC, which were divided into PBD group (n=36) and non-PBD group (n=47). The preoperative bilirubin level may be an independent risk factor affecting the liver regeneration rate (P=0.014) and postoperative liver insufficiency (P=0.016, odds ratio=1.016, b=0.016, 95% CI=1.003--1.029). For patients whose initial bilirubin level was >200 mmol/L (n=45), PBD resulted in better liver regeneration in the early stage (P=0.006) and reduced the incidence of postoperative liver insufficiency [P=0.012, odds ratio=0.144, 95% confidence interval (CI)=0.031--0.657]. The cut-off value of bilirubin was 103.15 mmol/L based on the liver regeneration rate. Patients with a preoperative bilirubin level of ≤103.15 mmol/L shown a better liver regeneration (P<0.01) and lower incidence of postoperative hepatic insufficiency (P=0.011, odds ratio=0.067, 95% CI=0.008--0.537). Conclusion: For HC patients undergoing hemi-hepatectomy whose initial bilirubin level is >200 mmol/L, PBD may result in better liver regeneration and reduce the incidence of postoperative liver insufficiency. Preoperative bilirubin levels ≤103.15 mmol/L maybe recommended for leading to a better liver regeneration and lower incidence of postoperative hepatic insufficiency. [ABSTRACT FROM AUTHOR]

Abstract Background Pancreaticoduodenectomy (PD) is a complex procedure and easily accompanied by healthcare-associated infections (HAIs). This study aimed to assess the impact of PBD on postoperative infections and clinical outcomes in PD patients. Methods The retrospective cohort study were conducted in a tertiary hospital from January 2013 to December 2022. Clinical and epidemiological data were collected from HAIs surveillance system and analyzed. Results Among 2842 patients who underwent PD, 247 (8.7%) were diagnosed with HAIs, with surgical site infection being the most frequent type (n = 177, 71.7%). A total of 369 pathogenic strains were detected, with Klebsiella pneumoniae having the highest proportion, followed by Enterococcu and Escherichia coli. Although no significant association were observed generally between PBD and postoperative HAIs, subgroup analysis revealed that PBD was associated with postoperative HAIs in patients undergoing robotic PD (aRR = 2.174; 95% CI:1.011–4.674; P = 0.047). Prolonging the interval between PBD and PD could reduce postoperative HAIs in patients with cholangiocarcinoma (≥4 week: aRR = 0.292, 95% CI 0.100–0.853; P = 0.024) and robotic PD (≤2 week: aRR = 3.058, 95% CI 1.178–7.940; P = 0.022). PBD was also found to increase transfer of patients to ICU (aRR = 1.351; 95% CI 1.119–1.632; P = 0.002), extended length of stay (P

Background: Hyperbilirubinemia is known to increase morbidity and mortality in patients undergoing liver resection for cholangiocarcinoma (CCA). Preoperative biliary drainage (PBD) in patients who have no acute cholangitis or require portal vein embolization is still debatable. The goal of this study is to investigate how PBD affects the surgical results after liver resection. Methods: Between October 2013 and December 2020, CCA patients presenting with obstructive jaundice who underwent liver resection were retrospectively reviewed. The pre-operative, peri-operative and post-operative characteristics were extracted. To compare the outcomes of the PBD and direct surgery groups, propensity score matching analysis (PSM) and multivariable risk regression analysis were used to analyze. Results: A total of 355 patients were enrolled, with 99 of them undergoing PBD. At diagnosis, those with PBD showed significantly greater bilirubin levels than those without (20.7 vs 9.6 ​mg/dL, p ​

Introduction: Pancreaticoduodenectomy (PD) is the only potentially curative treatment for pancreatic head adenocarcinoma. This study aimed to determine short-term outcomes of PD performed over one year at a newly established Hepato-Pancreatico-Biliary (HPB) unit in Khyber Pakhtun Khwa (KPK) Province of Pakistan. Material and methods: A retrospective analysis of a prospectively maintained Hospital Information System (HIS) was undertaken of all patients referred to the unit between May 2021 to August 2022. Data were collected from the medical records of patients in the hospital information system. Data were analyzed for primary location, age, complications, and operative parameters. Results: The primary site of disease were ampulla (n=18, 52.9%), pancreas (n=11, 32.4%), and duodenum (n=5, 14.7%). The median duration of surgery was 7 hours. 16 (47.1%) patients required blood transfusion either intraoperatively or in the peri-operative period. Patients with preoperative biliary drainage (PBD) were more likely to have multidrug-resistant positive bile cultures with a p-value of 0.2 [n=12(35.3%) vs n=5(14.7%)]. Overall morbidity was 38.2%. The most common complications were wound infection (n=12, 35.3%), delayed gastric emptying (n=6, 17.6%), and type B pancreatic fistula (n=3, 8.8%). The complication rate was higher in patients with biliary stenting [n=11(32.4%) vs n=2 (5.9%); p-value 0.06]. The median length of hospital stay for patients without complications was less (6 vs 12 days; P

Abstract Objectives Optimal stents for preoperative biliary drainage (PBD) for patients with possible resectable pancreatic cancer remain controversial, and risk factors for post‐endoscopic retrograde cholangiopancreatography pancreatitis (PEP), followed by PBD, are unknown. In this study, the efficacy and safety of fully covered self‐expandable metallic stents (FCSEMSs) and plastic stents (PSs) were compared, and the risk factors for PEP, followed by PBD, were investigated for patients with pancreatic cancer. Methods Consecutive patients with pancreatic cancer who underwent PBD between April 2005 and March 2022 were included. We retrospectively evaluated recurrent biliary obstruction, adverse events (AEs), and postoperative complications for FCSEMS and PS groups and investigated the risk factors for PEP. Results A total of 105 patients were included. There were 20 patients in the FCSEMS group and 85 patients in the PS group. For the FCSEMS group, the rate of recurrent biliary obstruction (0% vs. 25%, p = 0.03) was significantly lower. There was no difference in AE between the two groups. No significant differences were observed in the overall postoperative complications, but the volume of intraoperative bleeding was larger for the PS group than it was for the FCSEMS group (p < 0.001). From multivariate analysis, being female and lack of main pancreatic duct dilation were independent risk factors for pancreatitis (odds ratio, 5.68; p = 0.028; odds ratio, 4.91; p = 0.048). Conclusions FCSEMSs are thought to be preferable to PSs for PBD due to their longer time to recurrent biliary obstruction. Being female and the lack of main pancreatic duct dilation were risk factors for PEP.

Abstract Background 10‐mm self‐expandable metal stents (SEMSs) are commonly used for preoperative biliary drainage in pancreatic cancer. However, smaller diameter SEMSs have attracted attention with the attempt to reduce stent‐related adverse events (AEs). Methods We retrospectively analyzed consecutive borderline resectable pancreatic cancer patients who underwent neoadjuvant therapy and fully covered SEMS (FCSEMS) placement from April 2015 to May 2023. The primary outcome was stent‐related non‐event rate (NER), which was defined as the rate of completion of surgery without developing any preoperative events (recurrent biliary obstruction [RBO] or stent‐related AEs). Secondary outcomes included stent‐related AEs, causes of RBO, and cumulative incidence of RBO. Risk factors for pancreatitis, RBO, and stent migration were also examined. Results A total of 76 patients were included (6‐mm group: 23; 10‐mm group: 53). Stent‐related NER (57% vs. 64%, p = 0.610), stent‐related AEs (4% vs. 15%, p = 0.263), overall RBO rates (39% vs. 23%, p = 0.168), cumulative incidence of RBO (hazard ratio, 2.24; 95% confidence interval, 0.95–5.25; p = 0.065) were not significantly different between the two groups. Tumor involvement of the pancreatic duct was identified as a risk‐reducing factor for pancreatitis, while an FCSEMS diameter of 6 mm was not identified as a risk factor for RBO and stent migration. Conclusions Stent‐related NER was not significantly affected by FCSEMS diameter. Further studies are needed to confirm the usefulness of 6‐mm diameter FCSEMS for preoperative biliary drainage in patients with borderline resectable pancreatic cancer.

Background: Pancreatic head cancer accompanied by obstructive jaundice is a common clinical situation. The aim of this study was to assess the impact of preoperative biliary drainage (PBD) on clinical outcomes in patients with severe obstructive jaundice. Methods: Patients with a bilirubin level of ≥250 μmol/L at diagnosis who underwent PBD were included. The primary endpoints and secondary endpoints were the postoperative severe complications rates. Secondary endpoints were the degree of improvement in general condition, predictors of severe postoperative complications, and the impact of PBD on patients with bilirubin levels >300 μmol/L. Results: In total, 289 patients were included, and 188 patients (65.1%) underwent PBD. The patients who met the American Society of Anesthesiologists (ASA) classification II–III stages decreased from 119 to 100 (P = 0.047) after PBD. The overall severe complications were significantly more frequent in the direct surgery (DS) group than in the PBD group (34.7% vs. 22.9%, P = 0.031), especially the postoperative hemorrhage (6/43 [14.0%] vs. 9/35 [25.7%], P = 0.038) and intra-abdominal infection (6/43 [14.0%] vs. 10/35 [28.6%], P = 0.018). The ASA classifications II–III (odds ratio [OR]=2.89, 95% confidence interval [CI]: 1.38–4.31), P = 0.01) and DS (OR = 3.65, 95% CI: 1.45–7.08; P = 0.003) were independently associated with severe postoperative complications. The occurrence rate of severe postoperative complications in patients with a bilirubin level >300 μmol/L who underwent PBD was significantly lower than in patients who underwent DS (25.6% vs. 40.6%, P = 0.028), but the benefit of PBD was not observed in patients who had a bilirubin level between 250 and 300 μmol/L. Conclusion: PBD is useful in reducing severe postoperative complications, especially in patients with bilirubin levels >300 μmol/L.

Endoscopic transpapillary approach by endoscopic retrograde cholangiopancreatography (ERCP) is the established technique for preoperative biliary drainage (PBD). Recently, endoscopic ultrasound-guided biliary drainage (EUS-BD) has been reported to be a useful alternative technique after ERCP fail. However, the optimal strategy remain controversial. This review summarizes the literature on EUS-BD techniques for PBD with a literature search using PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials database between 2000 and 2023 using keywords for 'preoperative biliary drainage' and all types of EUS-BD techniques. As there is no consensus on the optimal EUS-BD technique for PBD, selection of the EUS-BD approach depends on the patient's condition, the biliary obstruction site, the anastomosis after surgical intervention, and the preference of the endoscopist. However, we consider that EUS-HGS using a dedicated plastic stent may have some advantages in the adverse impact of surgical procedure because the location where the fistula is created by EUS-HGS is away from the site of the surgical procedure. Although there remain many issues that require further investigation, EUS-BD can be a feasible and safe alternative method of PBD for malignant biliary obstruction after ERCP fail. [ABSTRACT FROM AUTHOR]

Abstract Background Biliary obstruction which is a major complication of pancreas and periampullary tumors could result in cholangitis, coagulopathies, gastrointestinal symptoms, and impaired wound healing. Pancreaticoduodenectomy (PD) is still the standard approach for pancreas resection and imposes high risk of morbidity and mortality to patients. To reduce the high risk of PD and address the biliary obstruction, the use of preoperative biliary stenting was increased. However, available literature doubts its efficiency. Methods A total of 147 patients who underwent PD between September 2012, and February 2022, at three medical centers were identified. Patients were grouped based on biliary stent placement. Non-jaundiced patients with and without preoperative biliary drainage (PBD) were compared. Results The incidence of overall complications (34.2% versus 45.8%) and mortality (17.8% versus 24.3%) did not differ in the PBD group compared to the no PBD group. There was no difference in complications and mortality in non-jaundiced patients with and without PBD. Patients with drainage duration of > 30 days experienced more overall complications compared to patients with less than 30 days drainage duration (12 (50.0%) and three (15.8%) patients, respectively, p-value = 0.019). Conclusions PBD does not significantly increase the post-operative burden on patients who undergo PD. However, we cannot overlook the financial burden that PBD places on the patient and the healthcare system, as well as the difficulties related to endoscopic retrograde cholangiopancreatography (ERCP). Therefore, biliary stenting should not be routinely practiced in the absence of a valid indication, such as severe jaundice, pruritus, cholangitis, delayed surgery for neoadjuvant treatment, or referral to a tertiary facility.

Purpose: The present study evaluated the potential effects of biliary drainage before pancreaticoduodenectomy on postoperative outcomes and presented the details of a surgeon's 6 years of experience. Methods: All consecutive pancreatoduodenectomies performed from 2015 to 2021 were retrospectively analyzed. The study population was divided into two groups: the stented group (Group I) and the nonstented group (Group II). Patient demographic data and clinical characteristics were compared between the two groups. Results: This study comprised 106 individuals who underwent pancreaticoduodenectomy for periampullary tumors. The median age of the patients was 64.41 ± 11.67 years, and 65 (61.3%) were males. Sixty-seven patients (63.2%) received biliary drains (stented group), and 39 (36.8%) patients did not (nonstented group). Total bilirubin values (6.39 mg/dl) were higher in the nonstented patient group than in the stented group. The rate of total complications was significantly higher in the stented group than in the nonstented group [please check this carefully] (p < 0.05). The length of stay, operation time and pancreatic fistula were found to be higher in the stented group than in the nonstented group. Conclusions: Although the total bilirubin value was higher in the nonstented patient group than in the stented group, preoperative biliary drainage increased postoperative complication rates, operation time, and hospital stay. An advanced age and the presence of stents were independent risk factors influencing morbidity development according to the multivariate analysis. [ABSTRACT FROM AUTHOR]

Background: No large studies have addressed the role of endoscopic-ultrasound biliary drainage (EUS-BD) as preoperative biliary drainage (PBD) for malignant extrahepatic biliary obstruction (MEBO). We aimed to discuss the outcomes of EUS antegrade stent placement (EUS-AG) in the preoperative and palliative setting. Methods: Retrospective review of patients who underwent EUS-AG for MEBO between December 2019 and December 2021 was done. Primary outcome measures were technical success and clinical success. Secondary outcome measures were number of days of hospitalization postprocedure, adverse events related to EUS-AG procedure, morbidity related to surgery, and 3-month mortality after surgery. Results: 54 patients underwent attempt for EUS-AG (mean age 54.8 ± 12.1 years; female 44.4%). Most common primary cancer was pancreatic cancer in 42.1% (23/54) patients. Indication was palliative in 34 (62.9%) patients and PBD in 20 (37%) patients. Level of block was distal in 35 (64.8%) and proximal in 19 (35.1%) patients. Technical success of EUS-AG was 88.7% (47/53). Clinical success was seen in 95.7% (45/47) patients. Median number of days of hospitalization postprocedure was 1 day. No procedure-related severe adverse events were seen. Of 20 patients who underwent EUS-AG as PBD, 19 had technical success (95%) with clinical success in 94.5% (18/19). Surgery was performed in 11 patients, of whom 10 patients underwent successful PPPD (one intraoperative liver metastasis). Two patients had Clavein–Dindo III/IV complication post-PPPD, with one mortality within 30 days of surgery. Conclusion: EUS-AG is safe and effective after failed ERCP in both preoperative and palliative setting. [ABSTRACT FROM AUTHOR]

Background/Purpose: The benefits of anti‐reflux metal stents, used for treating biliary obstruction in patients receiving neoadjuvant chemotherapy (NAC) for pancreatic cancer, are yet unknown. Herein, the safety and efficacy of the novel duckbill‐type anti‐reflux metal stent (D‐ARMS) were prospectively evaluated for biliary drainage. Additionally, the incidence of recurrent biliary obstruction (RBO) after placement of D‐ARMS vs conventional covered self‐expandable metal stents (CCSEMSs) was retrospectively compared. Methods: Patients who received D‐ARMS (n = 33) for treatment of distal biliary obstruction before NAC between September 2019 and January 2021 and those that received CCSEMSs (n = 38) between January 2013 and August 2019 were included in the historical control group. Technical and clinical successes, rate of RBO, and cumulative incidence of RBO were compared between the two groups. Results: The technical success rate was 100% for both the D‐ARMS and CCSEMS groups, and the clinical success rate were not significantly different (93.9% and 89.5%, respectively; P =.68). In the multivariate analysis, D‐ARMS was identified as the independent factor for cumulative incidence of RBO (P =.03). The cumulative incidence of RBO was significantly lower in the D‐ARMS group than that in the CCSEMS group (P =.04). Conclusions: D‐ARMS is safe and effective for patients receiving NAC. [ABSTRACT FROM AUTHOR]

Summary: Background/objective: Complete resection is the most effective treatment of hilar cholangiocarcinoma (HC) but may result in high morbidity and mortality. Most HC patients have jaundice, and preoperative biliary drainage may reduce their risk of obstructive jaundice. ERCP and PTBD have been advocated for this purpose. This retrospective study investigated the influence of ERCP versus PTBD versus their combination on the short-term outcomes of curative HC resection. Methods: Patients having curative HC resection with preoperative biliary drainage in a span of 26 years were reviewed and divided into groups according to drainage modality. Drainage-related and surgical complications and hospital mortality were compared between groups. Intention-to-treat analysis using a separate set of initial drainage data was performed. Results: Eighty-six patients were divided into: Group A, ERCP only, n = 32 (32/86 = 37.2%); Group B, PTBD only, n = 10 (10/86 = 11.6%); Group C, ERCP + PTBD, n = 44 (44/86 = 51.2%). International normalized ratio was significantly higher in Group B (p = 0.008). The three groups were comparable in operative details, hospital stay, and mortality. Fifty-two patients had postoperative complications. Significantly more patients in Groups A and C had subphrenic abscess (A: 25%, B: 0%, C: 9.1%; p = 0.035) and subsequent radiological drainage. Group A had insignificantly more patients with wound infection (31.3% vs 10% vs 22.7%, p = 0.334), chest infection (28.1% vs 20% vs 11.4%, p = 0.178), and urinary tract infection (6.3% vs 0% vs 0%, p = 0.133). The three groups had similar rates of major complications (p = 0.501). They also had comparable survival outcomes (overall, p = 0.370; disease-free, p = 0.569). Fifteen and 71 patients received PTBD and ERCP respectively as first drainage mode. These two groups were comparable in liver function, preoperative comorbidity, intraoperative details, and postoperative outcomes. Conclusion: In the preoperative management of HC, the use of ERCP, PTBD or their combination is acceptable and can optimize patients’ condition for curative HC resection.

Abstract Background The perioperative morbidity after pancreatoduodenectomy (PD) is mostly influenced by intraabdominal complications which are often associated with infections. In patients with preoperative biliary drainage (PBD), the risk for postoperative infections may be even elevated. The aim of this study is to explore if isolated infectious complications without intraabdominal focus (iiC) can be observed after PD and if they are associated to PBD and antibiotic prophylaxis with potential conclusions for their treatment. Methods During a 10-year period from 2009 to 2019, all consecutive PD were enrolled prospectively in a database and analyzed retrospectively. Bacteriobilia (BB) and Fungibilia (FB) were examined by intraoperatively acquired smears. A perioperative antibiotic prophylaxis was performed by Ampicillin/Sulbactam. For this study, iiC were defined as postoperative infections like surgical site infection (SSI), pneumonia, unknown origin etc. Statistics were performed by Fisher’s exact test and Mann Whitney U test. Results A total of 426 PD were performed at the Vivantes Humboldt-hospital. The morbidity was 56% (n = 238). iiC occurred in 93 patients (22%) and accounted for 38% in the subgroup of patients with postoperative complications. They were not significantly related to BB and PBD but to FB. The subgroup of SSI, however, had a significant relationship to BB and FB with a poly microbial profile and an accumulation of E. faecalis, E. faecium, Enterobacter, and Candida. BB was significantly more frequent in longer lay of PBD. Resistance to standard PAP and co-existing resistance to broad spectrum antibiotics is frequently found in patients with iiC. The clinical severity of iiC was mostly low and non-invasive therapy was adequate. Their treatment led to a significant prolongation of the hospital stay. Conclusions iiC are a frequent problem after PD, but only in SSI a significant association to BB and FB can be found in our data. Therefore, the higher resistance of the bacterial species to routine PAP, does not justify broad spectrum prophylaxis. However, the identification of high-risk patients with BB and PBD (length of lay) is recommended. In case of postoperative infections, an early application of broad-spectrum antibiotics and adaption to microbiological findings from intraoperatively smears may be advantageous.

Abstract Background The efficacy of preoperative biliary drainage (PBD) has been debated for several decades, and yet indications for PBD remain controversial. The aim of this study was to compare the postoperative morbidity and mortality in patients with malignant obstructive jaundice undergoing direct surgery versus surgery with PBD. Methods All consecutive patients with malignant obstructive jaundice who underwent radical resection between June 2017 and December 2019 at Zhongshan Hospital were analyzed retrospectively. The study population was divided into two groups: PBD group (PG) and direct surgery group (DG). The subgroups were chosen based on the site of obstruction. Perioperative indicators and postoperative complications were compared and analyzed. Results A total of 290 patients were analyzed. Postoperative complications occurred in 134 patients (46.4%). Patients in the PG group had a lower overall rate of postoperative complications compared with the DG group, with perioperative total bilirubin (TB) identified as an independent risk factor in multivariate analysis (hazard ratio = 1.004; 95% confidence interval 1.001–1.007; P = 0.017). Subgroup analysis showed that PBD reduced the complication rate in patients with proximal obstruction. In the proximal-obstruction subgroup, a preoperative TB level > 162 μmol/L predicted postoperative complications. Conclusions PBD may reduce the overall rate of postoperative complications among patients with proximal malignant obstructive jaundice. Trial registration ClinicalTrials.gov, 2018ZSLC 24 . Registered May 17, 2018, https://clinicaltrials.gov/ .

Background: Biliary obstruction which is a major complication of pancreas and periampullary tumors could result in cholangitis, coagulopathies, gastrointestinal symptoms, and impaired wound healing. Pancreaticoduodenectomy (PD) is still the standard approach for pancreas resection and imposes high risk of morbidity and mortality to patients. To reduce the high risk of PD and address the biliary obstruction, the use of preoperative biliary stenting was increased. However, available literature doubts its efficiency.Methods: A total of 147 patients who underwent PD between September 2012, and February 2022, at three medical centers were identified. Patients were grouped based on biliary stent placement. Non-jaundiced patients with and without preoperative biliary drainage (PBD) were compared.Results: The incidence of overall complications (34.2% versus 45.8%) and mortality (17.8% versus 24.3%) did not differ in the PBD group compared to the no PBD group. There was no difference in complications and mortality in non-jaundiced patients with and without PBD. Patients with drainage duration of > 30 days experienced more overall complications compared to patients with less than 30 days drainage duration (12 (50.0%) and three (15.8%) patients, respectively, p-value = 0.019).Conclusions: PBD does not significantly increase the post-operative burden on patients who undergo PD. However, we cannot overlook the financial burden that PBD places on the patient and the healthcare system, as well as the difficulties related to endoscopic retrograde cholangiopancreatography (ERCP). Therefore, biliary stenting should not be routinely practiced in the absence of a valid indication, such as severe jaundice, pruritus, cholangitis, delayed surgery for neoadjuvant treatment, or referral to a tertiary facility. [ABSTRACT FROM AUTHOR]

Background: Preoperative biliary drainage (PBD) is useful in resectable periampullary cancer with obstructive jaundice. Whether it is better than direct surgery (DS) in terms of postoperative complications andmortality is controversial. Methods: All cases of successful pancreaticoduodenectomy (PD) in patients with periampullary cancer with obstructive jaundice performed between January 2016 and January 2021 were retrospectively reviewed. Endoscopic PBD was performed; data pertaining to serum bilirubin level, procedural technique, and duration before surgery were obtained. The incidence of postoperative complications and survival rate were compared between the PBD and DS group. Results: A total of 104 patients (PBD, n = 58; DS, n = 46) underwent curative PD. The mean age was 63.8 ± 10 years and 53 (51%) were male. Age, body mass index (BMI), sex, Eastern Cooperative Oncology Group status, presence of comorbid disease, initial laboratory results, and pathological diagnoses were not significantly different between the two groups. The incidence of postoperative complications was 58.6% in the PBD group while 73.9% in the DS group (relative risk [RR] 1.26, 95% confidence interval [CI] 0.92, 1.73, p=0.155) and the difference was not significant except in bile leakage (RR 8.83, 95% CI 1.26, 61.79, p = 0.021) and intraoperative bleeding (RR 3.97, 95% CI 0.88, 17.85, p = 0.049) which were higher in the DS group. The one-year survival rate was slightly less in the DS group but the difference was not statistically significant. The independent predictors for death within 1-year were intraoperative bleeding and preoperative total bilirubin > 14.6 mg/dL. Conclusions: PBD in resectable malignant distal biliary obstruction showed no benefit in terms of 1-year survival over DS approach. But it demonstrated the benefit of lower risks of intraoperative bleeding, and bile leakage. Additionally, the level of pre-operative bilirubin level of over 14.6 mg/dL and having intraoperative bleeding were associated with a lower 1-year survival in such patients. Overall, PBD may be not necessary for all resectable periampullary cancer patients, but there might be a role in those with severely jaundice (>14.6 mg/dL), as it helps lower risk of intraoperative bleeding, and might lead to a better survival outcome. [ABSTRACT FROM AUTHOR]

Background and objectives: Obstructive jaundice is common in patients with pancreaticobiliary malignancies. Preoperative biliary drainage (PBD) can alleviate cholestasis; however, no consensus has been reached on the impact of PBD on the incidence of surgery-related complications and patient survival. This study aimed to evaluate the effect among patients treated with PBD. Methods: This retrospective study examined the clinical and follow-up prognostic data of 160 patients with pancreaticobiliary malignancies who underwent pancreaticoduodenectomy (PD) at Beijing Friendship Hospital, Capital Medical University, from January 2016 to July 2020. Outcomes were compared between patients who underwent PBD (PBD group) and those who did not (control group). Changes in biochemical indicators were evaluated before and after drainage in the PBD group. Between-group differences in inflammatory indicators after PD were assessed using the Wilcoxon signedrank test. Postoperative complications were classified according to the Clavien-Dindo classification system. The effects of PBD and biliary drainage efficiency on postoperative complications were evaluated using the chi-square test and binary logistics regression. The Kaplan-Meier analysis was used for between-group comparison of survival analysis. Univariate and multivariate regression analyses were performed to identify prognostic factors of survival. Results: Total 160 patients were enrolled, the mean age of the study sample was 62.75 ± 6.75 years. The distribution of pancreaticobiliary malignancies was as follows: 34 cases of pancreatic head cancer, 61 cases of distal bile duct cancer, 20 cases of duodenal papilla cancer, 39 cases of duodenal ampullary cancer, and 6 cases of malignant intraductal papillary mucinous neoplasm (IPMN). PBD was performed in 90 of the 160 patients, with PBD performed using an endoscopic retrograde cholangiopancreatography (ERCP) approach in 55 patients and with percutaneous transhepatic cholangiography (PTC) used in the remaining 35 cases. The mean duration of drainage in the PBD group was 12.8 ± 8.8 days. The overall rate of complications was 48.05% (37/77) in the control group and 65.55% (59/90) in the PBD group with non-significant difference (c2 = 3.527, p=0.473). In logsitics regression analysis, PBD was also not a risk factor for postoperative complications OR=1.77, p=0.709). The overall rate of postoperative complications was significantly higher among patients who underwent PBD for >2 weeks (c2 = 6.102, p=0.013), with the rate of severe complications also being higher for this subgroup of PBD patients (c2 = 4.673, p=0.03). The overall survival time was 47.9 ± 2.45 months, with survival being slightly lower in the PBD group (43.61 ± 3.26 months) than in the control group (52.24 ± 3.54 months), although this difference was not significant (hazard ratio (HR)=0.65, p=0.104). Conclusion: In patients with malignant biliary obstruction, PBD does not affect the incidence of postoperative complications after pancreaticoduodenectomy nor does it affect patient survival. Prolonged biliary drainage (>2 weeks) may increase the incidence of overall postoperative complications and severe complications. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the bacterobilia in patients undergoing pancreaticoduodenectomy (PD) based on whether they carry a preoperative biliary drainage or not and to analyse if a targeted perioperative antibiotic treatment based on the expected microbiology leads in no differences in Surgical Site Infections (SSI) between the groups., Methods: Retrospective observational single-center study of patients undergoing pancreaticoduodenectomy with preoperative biliary stent (group P, Prosthesis) and without stent (group NP, No Prosthesis). Postoperative complications including SSI and its subtypes were analyzed after applying a targeted perioperative antibiotic treatment protocol with cefotaxime and metronidazole (group NP) and piperacillin-tazobactam (group P)., Results: Between January 2014 and December 2021, 127 patients were treated (84 in group NP and 43 in group P). Intraoperative cultures were positive in 16.7% (group NP) vs 76.7% (group P, p < 0.01). Microorganisms isolated in group NP included Enterobacterales (10.7%) and Enterococcus spp. (7.1%) with no Candida detected. In group P: Enterobacterales (51.2%), Enterococcus spp. (48.8%), and Candida (16.3%) were higher (p < 0.01%). No differences in morbidity and mortality were observed between the groups. SSI rate was 17.8% in group NP and 23.2% in group P (ns)., Conclusion: Bacterobilia differs in patients with biliary drainage, showing a higher presence of Enterobacterales, Enterococcus spp., and Candida. There were no differences in SSI incidence after applying perioperative antibiotic treatment tailored to the expected microorganisms in each group. This raises the need to reconsider conventional surgical prophylaxis in patients with biliary stent., (Copyright © 2024 AEC. Published by Elsevier España, S.L.U. All rights reserved.)

Background/purpose: The usefulness of endoscopic biliary stenting by deploying a plastic stent suprapapillary, called inside-stent (IS) placement, as preoperative biliary drainage (PBD) for perihilar biliary malignancy (PHBM) has been demonstrated. This study investigated risk factors for recurrent biliary obstruction (RBO) after IS placement., Methods: Consecutive patients with potentially resectable PHBM treated with IS placement as PBD between 2017 and 2023 at Nagoya University Hospital were retrospectively reviewed., Results: A total of 157 patients were included, with RBO occurring in 34 (22%) patients. The non-RBO rates were 83% at 30 days, 77% at 60 days, and 57% at 90 days. The most common cause of RBO was stent occlusion (n = 14), followed by segmental cholangitis (n = 12) and stent migration (n = 8). Stent migration and occlusion occurred more frequently within and after 1 week post-stenting, respectively. In multivariate analysis, biliary infection before IS was the sole risk factor for RBO, with a hazard ratio of 2.404 (95% confidence interval 1.163-4.972; p = .018). This risk was reduced by temporary endoscopic nasobiliary drainage prior to definitive IS placement., Conclusions: Biliary infection before IS was identified as an independent risk factor for RBO in patients with PHBM with IS as PBD., Clinical Trial Register: Clinical trial registration number: UMIN000025631., (© 2024 Japanese Society of Hepato‐Biliary‐Pancreatic Surgery.)

Preoperative biliary drainage (PBD) was primarily introduced to reduce perioperative complications following hepato-pancreato-biliary surgeries. There is no proper consensus on the routine use of PBD before pancreaticoduodenectomy (PD). This is a prospective observational study of patients who underwent PD between July 2013 and December 2014. The study group was divided into two groups based on whether a preoperative biliary drainage was performed or not. The intraoperative and postoperative complications were compared among the two groups. A total of 59 patients, predominantly males (64.4%) with a median age of 58 years, were included in study. All except 5 (8.5%) had undergone PD for periampullary malignancy. Thirty-eight patients (64.4%) underwent an upfront PD and the remaining 21 (35.5%) had undergone PBD. Cholangitis was the indication for PBD in all patients. The mean operative time (307.89 ± 52.51 min vs. 314.29 ± 36.273; p value = 0.62) and postoperative complications like delayed gastric emptying (63.2% vs. 61.9%; p value-0.924), postoperative pancreatic fistula (21.1% vs. 33.3%; p value 0.3), post-pancreaticoduodenectomy haemorrhage (5.3% vs. 9.5%; p value-0.611) and mean in-hospital stay were comparable among two groups. Even though the incidence of positive intraoperative bile cultures is significantly higher among the stented group (95.2% vs. 26.3%; p value = 0.0), no significant difference in surgical site infections (47.6% vs. 28.9%; p value 0.152) was noted. The overall mortality was 1.7% (1/59; grade C PPH). This study showed no significant difference in the postoperative complications following PBD despite increase in bile culture positivity. However, notable differences in the spectrum of microbial growths between stented and non-stented groups were observed. [ABSTRACT FROM AUTHOR]

Purpose: The treatment of choice for patients presenting with obstructive cholestasis due to periampullary carcinoma is oncologic resection without preoperative biliary drainage (PBD). However, resection without PBD becomes virtually impossible in patients with obstructive cholangitis or severely impaired liver cell function. The appropriate duration of drainage by PBD has not yet been defined for these patients. Methods: A retrospective analysis was conducted on 170 patients scheduled for pancreatic resection following biliary drainage between January 2012 and June 2018 at the University Hospital Dresden in Germany. All patients were deemed eligible for inclusion, regardless of the underlying disease entity. The primary endpoint analysis was defined as the overall morbidity (according to the Clavien-Dindo classification). Secondary endpoints were the in-hospital mortality and malignancy adjusted overall and recurrence-free survival rates. Results: A total of 170 patients were included, of which 45 (26.5%) and 125 (73.5%) were assigned to the short-term (< 4 weeks) and long-term (≥ 4 weeks) preoperative drainage groups, respectively. Surgical complications (Clavien-Dindo classification > 2) occurred in 80 (47.1%) patients, with significantly fewer complications observed in the short-term drainage group (31.1% vs. 52%; p = 0.02). We found that long-term preoperative drainage (unadjusted OR, 3.386; 95% CI, 1.507–7.606; p < 0.01) and periampullary carcinoma (unadjusted OR, 5.519; 95% CI, 1.722–17.685; p-value < 0.01) were independent risk factors for postoperative morbidity, based on the results of a multivariate regression model. The adjusted overall and recurrence-free survival did not differ between the groups (p = 0.12). Conclusion: PBD in patients scheduled for pancreatic surgery is associated with substantial perioperative morbidity. Our results indicate that patients who have undergone PBD should be operated on within 4 weeks after drainage. [ABSTRACT FROM AUTHOR]

Expanding indications for neoadjuvant chemotherapy (NAC) for resectable pancreatic cancer prolong the period from diagnosis to surgery. In resectable pancreatic cancer with malignant biliary obstruction (MBO), the biliary drainage method without any biliary events is ideally required to safely perform NAC as planned. Plastic stents (PS) have been traditionally used for preoperative biliary drainage; however, recently, covered self-expandable metallic stents (CSEMS) have emerged as a tool for preoperative biliary drainage. To compare CSEMS with PS for preoperative biliary drainage in the management of resectable pancreatic cancer with MBO. In this multicenter retrospective cohort study, we compared CSEMS with PS for preoperative biliary drainage in patients with pancreatic cancer at three tertiary care centers between 2008 and 2019. Of the 120 enrolled patients, 45 underwent CSEMS and 75 underwent PS. No significant difference was observed in the basic characteristics between the groups. The rate of recurrent biliary obstruction (RBO) was significantly lower and the time to RBO was significantly longer in the CSEMS group. In multivariate analysis, CSEMS was an independent factor for a longer RBO. However, pancreatitis and cholecystitis were more common in the CSEMS group. The surgery-related adverse events were not significantly different between the two groups, except for longer surgery time and time to discharge in the CSEMS group. CSEMS for preoperative endoscopic biliary drainage in patients with pancreatic cancer reduced RBO, although the risk for pancreatitis or cholecystitis could be increased. [ABSTRACT FROM AUTHOR]

Complete resection is the most effective treatment of hilar cholangiocarcinoma (HC) but may result in high morbidity and mortality. Most HC patients have jaundice, and preoperative biliary drainage may reduce their risk of obstructive jaundice. ERCP and PTBD have been advocated for this purpose. This retrospective study investigated the influence of ERCP versus PTBD versus their combination on the short-term outcomes of curative HC resection. Patients having curative HC resection with preoperative biliary drainage in a span of 26 years were reviewed and divided into groups according to drainage modality. Drainage-related and surgical complications and hospital mortality were compared between groups. Intention-to-treat analysis using a separate set of initial drainage data was performed. Eighty-six patients were divided into: Group A, ERCP only, n = 32 (32/86 = 37.2%); Group B, PTBD only, n = 10 (10/86 = 11.6%); Group C, ERCP + PTBD, n = 44 (44/86 = 51.2%). International normalized ratio was significantly higher in Group B (p = 0.008). The three groups were comparable in operative details, hospital stay, and mortality. Fifty-two patients had postoperative complications. Significantly more patients in Groups A and C had subphrenic abscess (A: 25%, B: 0%, C: 9.1%; p = 0.035) and subsequent radiological drainage. Group A had insignificantly more patients with wound infection (31.3% vs 10% vs 22.7%, p = 0.334), chest infection (28.1% vs 20% vs 11.4%, p = 0.178), and urinary tract infection (6.3% vs 0% vs 0%, p = 0.133). The three groups had similar rates of major complications (p = 0.501). They also had comparable survival outcomes (overall, p = 0.370; disease-free, p = 0.569). Fifteen and 71 patients received PTBD and ERCP respectively as first drainage mode. These two groups were comparable in liver function, preoperative comorbidity, intraoperative details, and postoperative outcomes. In the preoperative management of HC, the use of ERCP, PTBD or their combination is acceptable and can optimize patients' condition for curative HC resection. [ABSTRACT FROM AUTHOR]

With the increasing use of neoadjuvant therapy (NAT) in patients with pancreatic cancer to reduce tumor burden on prognosis, preoperative biliary drainage (PBD) is becoming increasingly necessary. The aim of this study was to summarize the latest evidence and compare the clinical efficacy of metal stents (MS) and plastic stents (PS) in patients undergoing neoadjuvant therapy for operable pancreatic cancer. Eligible studies were searched in PubMed, Embase and Cochrane Library from their inception to September 2021. In this study, RevMan 5.4 was used to perform the analyses. Two randomized controlled trials (RCTs) and six retrospective studies with 316 patients were included. All patients had pancreatic cancer and received NAT before surgical resection. Meta-analysis showed that the rate of endoscopic reintervention in MS (26/143, 18%) group was lower than that of PS (122/153, 80%) group (P

Abstract Objectives Plastic stents (PS) used for preoperative biliary drainage (PBD) of pancreatic ductal adenocarcinomas (PDAC) tend to be associated with a high incidence of recurrent biliary obstruction (RBO). Although 10‐mm diameter fully covered self‐expanding metallic stents (FCSEMS) have come into use, vigilance is still required to prevent complications, such as cholecystitis and surgical site infection. The present study examined the efficacy and safety of the 6‐mm diameter FCSEMS for PBD. Methods The present retrospective study compared the incidence of complications associated with the use of 6‐mm FCSEMS and PS. The inclusion criteria were a diagnosis of PDAC and preoperative endoscopic biliary tract drainage performed at our institution between April 2012 and June 2019. Results Of the 51 patients enrolled, 25 and 26 patients received a PS and a 6‐mm FCSEMS, respectively. The RBO incidence was significantly lower in the 6‐mm FCSEMS group (7.7%) than in the PS group (40.0%) (p = 0.009), and time to RBO was significantly longer in the 6‐mm FCSEMS group (HR = 6.008, p = 0.021). The patency rate at three months after stent placement was significantly higher in the latter group (83.5% vs. 45.3%, p = 0.009, Log‐rank test). The groups did not differ significantly in terms of complications associated with PBD, such as cholecystitis and surgical site infection. Conclusion The present findings suggested that the 6‐mm FCSEMS may be an effective drainage device for use in PBD in PDAC treatment.

Background: The perioperative morbidity after pancreatoduodenectomy (PD) is mostly influenced by intraabdominal complications which are often associated with infections. In patients with preoperative biliary drainage (PBD), the risk for postoperative infections may be even elevated. The aim of this study is to explore if isolated infectious complications without intraabdominal focus (iiC) can be observed after PD and if they are associated to PBD and antibiotic prophylaxis with potential conclusions for their treatment.Methods: During a 10-year period from 2009 to 2019, all consecutive PD were enrolled prospectively in a database and analyzed retrospectively. Bacteriobilia (BB) and Fungibilia (FB) were examined by intraoperatively acquired smears. A perioperative antibiotic prophylaxis was performed by Ampicillin/Sulbactam. For this study, iiC were defined as postoperative infections like surgical site infection (SSI), pneumonia, unknown origin etc. Statistics were performed by Fisher's exact test and Mann Whitney U test.Results: A total of 426 PD were performed at the Vivantes Humboldt-hospital. The morbidity was 56% (n = 238). iiC occurred in 93 patients (22%) and accounted for 38% in the subgroup of patients with postoperative complications. They were not significantly related to BB and PBD but to FB. The subgroup of SSI, however, had a significant relationship to BB and FB with a poly microbial profile and an accumulation of E. faecalis, E. faecium, Enterobacter, and Candida. BB was significantly more frequent in longer lay of PBD. Resistance to standard PAP and co-existing resistance to broad spectrum antibiotics is frequently found in patients with iiC. The clinical severity of iiC was mostly low and non-invasive therapy was adequate. Their treatment led to a significant prolongation of the hospital stay.Conclusions: iiC are a frequent problem after PD, but only in SSI a significant association to BB and FB can be found in our data. Therefore, the higher resistance of the bacterial species to routine PAP, does not justify broad spectrum prophylaxis. However, the identification of high-risk patients with BB and PBD (length of lay) is recommended. In case of postoperative infections, an early application of broad-spectrum antibiotics and adaption to microbiological findings from intraoperatively smears may be advantageous. [ABSTRACT FROM AUTHOR]

Obstructive jaundice is a major symptom of pancreatic head cancer, and although its amelioration is required before scheduling chemotherapy, the decision to perform biliary drainage for resectable pancreatic cancer has remained controversial. In recent years, the effectiveness of neoadjuvant therapy for pancreatic cancer has been reported. Preoperative biliary drainage has become increasingly necessary, making the choice of stent an important one; thus, the longer the waiting period extends through neoadjuvant chemotherapy, the more durable stents – such as self‐expandable metallic stents, rather than plastic stents – would be desired as an option. Still, there is insufficient evidence regarding surgical outcomes and long‐term prognosis, and further confirmatory studies are needed. Through this review, we aim to provide an update on the characteristics of biliary stents and preoperative biliary drainage for potentially resectable pancreatic cancer. [ABSTRACT FROM AUTHOR]

Background: The efficacy of preoperative biliary drainage (PBD) has been debated for several decades, and yet indications for PBD remain controversial. The aim of this study was to compare the postoperative morbidity and mortality in patients with malignant obstructive jaundice undergoing direct surgery versus surgery with PBD. Methods: All consecutive patients with malignant obstructive jaundice who underwent radical resection between June 2017 and December 2019 at Zhongshan Hospital were analyzed retrospectively. The study population was divided into two groups: PBD group (PG) and direct surgery group (DG). The subgroups were chosen based on the site of obstruction. Perioperative indicators and postoperative complications were compared and analyzed. Results: A total of 290 patients were analyzed. Postoperative complications occurred in 134 patients (46.4%). Patients in the PG group had a lower overall rate of postoperative complications compared with the DG group, with perioperative total bilirubin (TB) identified as an independent risk factor in multivariate analysis (hazard ratio = 1.004; 95% confidence interval 1.001–1.007; P = 0.017). Subgroup analysis showed that PBD reduced the complication rate in patients with proximal obstruction. In the proximal-obstruction subgroup, a preoperative TB level > 162 μmol/L predicted postoperative complications. Conclusions: PBD may reduce the overall rate of postoperative complications among patients with proximal malignant obstructive jaundice. Trial registration: ClinicalTrials.gov, 2018ZSLC 24. Registered May 17, 2018, https://clinicaltrials.gov/. [ABSTRACT FROM AUTHOR]

Background/Aim: The aims of this study were to clarify optimal type and management of preoperative biliary drainage (PBD) in patients with obstructive jaundice who underwent pancreatoduodenectomy (PD). Patients and Methods: A total of 156 patients with obstructive jaundice who underwent PD were enrolled. We compared clinical variables and postoperative complications between patients who underwent endoscopic retrograde biliary drainage (ERBD) and those who underwent endoscopic nasobiliary drainage (ENBD). Results: All patients underwent PBD, with ERBD in 117 and ENBD in 39. The incidence of infectious complications and clinically relevant pancreatic fistula (CRPF) were significantly higher in the ERBD group (39% vs. 13%, p=0.012 and 39% vs. 10%, p<0.00001, respectively). However, there was no significant difference in the postoperative complications between two groups when the duration of drainage exceeded 30 days. Conclusion: ERBD should not be performed in patients with obstructive jaundice prior to PD because of the increased rates of infectious complications and CR-PF following PD, and ENBD should be chosen instead. Furthermore, PD should be performed within 30 days of drainage period in patients with ENBD. [ABSTRACT FROM AUTHOR]

Abstract Background In the management of operable hilar cholangiocarcinoma (HC) patients with hyperbilirubinemia, preoperative biliary drainage is a measure to bring down the bilirubin to a certain level so as to avoid adverse postoperative outcomes that would otherwise result from hyperbilirubinemia. A cutoff value of bilirubin level in this context is needed but has not been agreed upon without controversy. This retrospective study aimed to identify a cutoff of preoperative bilirubin level that would minimize postoperative morbidity and mortality. Methods Data of patients having hepatectomy with curative intent for HC were analyzed. Discriminative analysis was performed to identify the preoperative bilirubin level that would make a survival difference. The identified level was used as the cutoff to divide patients into two groups. The groups were compared. Results Ninety patients received hepatectomy with curative intent for HC. Their median preoperative bilirubin level was 23 μmol/L. A cutoff preoperative bilirubin level of 75 μmol/L was derived from Youden’s index (sensitivity 0.333; specificity 0.949) and confirmed to be optimal by logistic regression (relative risk 9.250; 95% confidence interval 1.932–44.291; p = 0.005), with mortality shown to be statistically different at 90 days (p = 0.008). Patients were divided into Group A (≤75 μmol/L; n = 82) and Group B (> 75 μmol/L; n = 8). Group B had a higher preoperative bilirubin level (p

Abstract Background The effect and safety of preoperative biliary drainage (PBD) in patients with perihilar cholangiocarcinoma are still controversial; the aim of our study is to evaluate all aspects of PBD. Methods All included studies featured PBD versus non-PBD (NPBD) groups were from 1996 to 2019 and were extracted from Cochrane Library, Embase, PubMed, and Science Citation Index Expanded. Results Sixteen studies met the inclusion criteria and were included in this analysis. PBD may lead to a significantly higher incidence of overall morbidities (OR 0.67, 95% CI 0.53, 0.85; P = 0.0009) and intraoperative transfusions (OR 0.72, 95% CI 0.55, 0.94; P = 0.02); moreover, bile leakage (OR 0.58, 95% CI 0.24, 1.41; P = 0.04), infection (OR 0.31, 95% CI 0.20, 0.47; P < 0.00001), and cholangitis (OR 0.18, 95% CI 0.007, 0.48; P = 0.0007) are also related to PBD. However, NPBD was associated with more frequent hepatic insufficiency (OR 3.09, 95% CI 1.15, 8.31; P = 0.03). In the subgroup meta-analysis, the differences in the outcomes of bile leakage and overall morbidity lost significance between the PBD and NPBD groups when the mean total serum bilirubin (TSB) concentration was above 15 mg/dl. Conclusion Meta-analysis demonstrated that compared to NPBD, PBD is associated with a greater risk of several kinds of infection and morbidities, but its ability to reduce postoperative hepatic insufficiency cannot be ignored. In patients with a high TSB concentration, PBD tends to be a better choice. However, these results need to be confirmed in a future prospective randomized trial with large samples to clarify the effects and find a specific TSB concentration for PBD.

Abstract Background To compare the efficacy of endoscopic nasobiliary drainage (ENBD) and endoscopic biliary stenting (EBS) in preoperative biliary drainage (PBD). Methods ENBD and EBS related literature of patients with malignant biliary obstruction published before September 2019 were collected from PubMed, EMBASE, and Cochrane Library for comparison analysis. Revman 5.3 statistical software was used for analysis. Results Nine studies were used for our comparative study. A total of 1435 patients were included, which consisted of 813 in the ENBD group and 622 in the EBS group. Meta-analysis showed that patients with malignant biliary obstruction who received ENBD had reductions in the rates of preoperative cholangitis (RR = 0.46, 95% CI = 0.34–0.62, P < 0.00001), preoperative pancreatitis (RR = 0.69, 95% CI = 0.50–0.95, P = 0.02), stent dysfunction (RR = 0.58, 95% CI = 0.43–0.80, P = 0.0008), morbidity (RR = 0.77, 95% CI = 0.64–0.93, P = 0.007), and postoperative pancreatic fistula (RR = 0.65, 95% CI = 0.45–0.92, P = 0.02) compared with patients who received EBS. Conclusions The rates of preoperative cholangitis, preoperative pancreatitis, post-operative pancreatic fistula, stent dysfunction, and morbidity of ENBD patients were lower than those of EBS patients. In clinical practice, the physical condition of each patient and their tolerance should be fully considered. ENBD should be given priority. EBS should be replaced if stent dysfunction or intolerance occurs.

This study aimed to evaluate the effect of preoperative biliary drainage (PBD) on outcomes of pancreaticoduodenectomy (PD) in patients with biliary obstruction. We searched PubMed, EMBASE, Cochrane library, and Web of Science from database inception to 11 March 2021. We used the ROBINS-I tool and Cochrane risk of bias tool 2.0 to assess the risk of bias. The data were statistically analyzed using the RevMan software (Version 5.4). In all, 43 studies, including 23,076 patients, were analyzed, of which 13,922 patients were treated with PBD and 9154 were treated with no preoperative biliary drainage (NPBD). The morbidity , infection morbidity , and postoperative pancreatic fistulae (POPF) in patients undergoing PBD, were significantly higher than those in patients undergoing NPBD. Further, PBD may lead to a significantly worse 2- and 3-year overall survival (OS) rates. In subgroup meta-analysis, the differences in morbidity, POPF, and OS outcomes lost significance between the PBD and NPBD groups when the mean total serum bilirubin (TSB) concentration was below 15 mg/dl. Routine PBD still cannot be recommended because it showed no beneficial effect on postoperative outcomes. However, in patients with < 15 mg/dl TSB concentration, PBD tends to be a better choice. [ABSTRACT FROM AUTHOR]

Background/Purpose: Appropriate preoperative biliary drainage (PBD) is extremely important in patients with operable malignant perihilar biliary strictures. The aim of this study was to clarify the utility of inside stents in PBD. Methods: Eighty‐one patients with malignant perihilar biliary stricture who underwent endoscopic nasobiliary drainage (ENBD) as the first PBD method were enrolled. Biliary stenting was performed in 61 patients during the study course (41 patients—inside stent implanted in the bile duct; 20 patients—conventional stent placed across the papilla of Vater). Twenty patients continued ENBD until surgery. Treatment outcomes were compared among the three groups. Results: The re‐intervention rate was significantly lower in the inside stent group than in the conventional stent group and ENBD group (9.8% vs 40% and 35%, P =.013 and.030, respectively), and the time to re‐intervention was also significantly longer (log‐rank: P =.004 and.041, respectively). Of the five patients in the inside stent group who underwent neoadjuvant chemotherapy, only one required re‐intervention. There was no significant difference in the incidence of postoperative complications among the three groups. Conclusions: The inside stent may be a useful PBD method for patients with malignant perihilar biliary stricture. [ABSTRACT FROM AUTHOR]

The aim of the present study is to report the overall perioperative outcome of Whipple's procedure (WP) with particular attention to the impact of preoperative biliary drainage (PBD) on postoperative clinical outcome. All the patients who underwent WP at our institution between August 2007 and December 2019 were retrospectively reviewed. Impact of PBD and the stent-surgery interval on the postoperative clinical outcome of WP were analyzed. Of the total 404 patients, 254 (63%) were male. The median age at operation was 50 years. The overall morbidity was 57.7%. The most common complication was surgical site infection (SSI) (28.7%). POPF developed in 57 (14.1%) patients. Delayed gastric emptying, intra-abdominal collection, and postpancreatectomy hemorrhage developed in 82 (20%), 23 (5.7%), and 18 (4.5%) patients, respectively. PBD was performed in 175 (43%) patients. The median stent-surgery interval was 59 days. Postoperative overall complications and SSI were significantly more common in PBD patients. No significant difference in postoperative major complications or mortality was observed between PBD and no-PBD patients. Stent-surgery interval more than 6 weeks was not associated with increased postoperative complications or hospital stay. Similarly, PBD solely based on serum bilirubin ≥ 15 mg/dl has no beneficial effect on surgical outcome. The operative mortality was 4.2% (n = 17). The median postoperative hospital stay was 13 (7–68) days. PBD is associated with increased incidence of postoperative overall complications and SSI, but does not affect major complications or mortality. PBD-surgery interval greater than 6 weeks does not have a negative impact on postoperative clinical outcomes. [ABSTRACT FROM AUTHOR]

Biliary drainage before pancreaticoduodenectomy was introduced to decrease morbidity from obstructive jaundice. Recent retrospective and randomised data show that preoperative biliary drainage (PBD) increases perioperative infectious complications. Most patients presenting to our tertiary care centre have undergone drainage procedures prior to surgical consultation. We analysed the impact of PBD, specifically endoscopic stent placement, on the postoperative outcome of pancreaticoduodenectomy at our centre. A cohort of 87 patients undergoing pancreaticoduodenectomy from 2012 to 2016 was identified. Data was collected retrospectively and a comparative analysis of stented and nonstented patients was done. Comparison of the 23 stented patients was done with 23 nonstented patients after matching them for age, sex and bilirubin levels. Median total bilirubin level in stented patients was 10.2 mg/dl versus 7.7 mg/dl in nonstented patients. The infectious complication rate in the stented group was 39.1% versus 12.7% in the nonstented group (P value < 0.05). There was no difference in the anastomotic leak rate between the two groups. Time to curative surgery in the stented group was significantly more than in the nonstented group. Stented patients are at a higher risk for postoperative infectious complications. Patients with obstructive jaundice awaiting surgery should undergo selective biliary drainage after careful planning and discussion between the operating surgeon and the endoscopist. [ABSTRACT FROM AUTHOR]

Background: The efficacy of different types of preoperative biliary drainage for cholangiocarcinoma has been debated over the past two decades. Controversy concerning the use of percutaneous transhepatic biliary drainage (PTBD) versus endoscopic biliary drainage (EBD) still exists. This study aimed to compare the long-term outcomes between PTBD and EBD in patients with distal cholangiocarcinoma. Methods: Data of patients diagnosed with distal cholangiocarcinoma who underwent preoperative PTBD or EBD from January 1999 to December 2017 were analyzed retrospectively. Post-surgical outcomes, including the incidence of post-operative complications, peritoneal metastasis, disease-free survival, and overall survival, were analyzed. Survival analyses were also performed after propensity score matching in the PTBD and EBD groups. Results: The incidence of post-operative complications was similar in both groups. The 5-year estimated cumulative incidences for peritoneal metastasis were 14.7% and 7.2% in the PTBD and EBD groups, respectively (p = 0.192). The 5-year disease-free survival rates were 23.7% and 47.3% in the PTBD and EBD groups, respectively (p = 0.015). In the multi-variate analysis for overall survival, PTBD was an independent poor prognostic factor. The 5-year overall survival rates were 35.9% and 56.3% in the PTBD and EBD groups, respectively (hazard ratio 1.85, confidence interval 1.05–3.26, p = 0.035). The results after propensity score matching indicated a poorer prognosis in the PTBD group, with a 5-year survival rate of 35.9% in the PTBD group vs 56.0% in the EBD group (p = 0.044). Conclusion: PTBD should be considered as a negative prognostic factor in distal cholangiocarcinoma patients. [ABSTRACT FROM AUTHOR]

Background: Although routine preoperative biliary drainage (PBD) is generally not recommended for patients with malignant distal biliary obstruction (MDBO), it is still necessary in many cases. The objective of this study is to compare the effects of metal stents (MSs) and plastic stents (PSs) on PBD in patients with MDBO. Methods: All the randomized controlled trials (RCTs) that compared MS with PS for PBD and published from the date of database establishment to September 2020 were identified by searching the PubMed, EMBASE and Cochrane databases. Results: Five RCTs involving 445 patients were included. There were 201 cases in the MS group, with 244 in the PS group. Re‐interventions (relative risk (RR) = 0.40, 95% confidence interval (CI) 0.21–0.75, P = 0.004), stent occlusions (RR = 0.36, 95% CI 0.18–0.75, P = 0.006), postoperative complications (RR = 0.76, 95% CI 0.59–0.97, P = 0.03) and preoperative cholangitis (RR = 0.19, 95% CI 0.05–0.78, P = 0.02) were lower in the MS group than in the PS group. Preoperative pancreatitis (RR = 2.11, 95% CI 1.06–4.19, P = 0.03) was higher in the MS group than in the PS group. No significant difference was observed in the overall preoperative complications, postoperative pancreatic fistulas, delayed gastric emptying, wound infections and postoperative bleeding between these two groups. Conclusions: MS and PS exerted a similar effect on PBD, but PS had a higher risk of preoperative stent obstruction and postoperative complications, requiring more frequent interventions preoperatively. However, larger sample and higher quality RCTs are necessary for further verification. [ABSTRACT FROM AUTHOR]

Abstract Background and aim Endoscopic biliary drainage (EBD) and percutaneous biliary drainage (PTBD) are the two main strategies of preoperative biliary drainage (PBD) for resectable malignant biliary obstruction (MBO) worldwide, but which is better remains unclear. Seeding metastasis (SM) has been reported repeatedly in the recent decade, although it is rarely taken into consideration in the choice of PBD. Hence, a systematic review was badly warranted to evaluate the incidence of SM between PTBD and EBD in the preoperative treatment of MBO. Methods PubMed, MEDLINE, the Cochrane Library, and Web of Science were used to identify any potentially eligible studies comparing the incidence of SM between EBD and PTBD from Nov 1990 to Mar 2018. The effect size was determined by odds ratio (OR) with 95% confidence interval (CI). Results Ten studies were enrolled in this study, including 1379 cases in the EBD group and 1085 cases in the PTBD group. Results showed that the incidence of SM in the EBD group was significantly lower than that in the PTBD group (10.5% vs. 22.0%, OR = 0.35, 95% CI 0.23~0.53). Subgroup analysis stratified by the definition of SM showed that the pooled ORs for peritoneal metastasis and tube-related SM between EBD and PTBD were 0.42 (95% CI 0.31~0.57) and 0.17 (95% CI 0.10~0.29), respectively. Subgroup analysis stratified by the location of MBO showed that the pooled ORs for the incidence of SM between EBD and PTBD for perihilar cholangiocarcinoma, distal cholangiocarcinoma, and pancreatic cancer were 0.27 (95% CI 0.13~0.56), 0.32 (95% CI 0.17~0.60), and 0.27 (95% CI 0.19~0.40), respectively. Conclusion EBD should be the optimal PBD for MBO considering the SM, but it deserved further validation.

Background/Aim: For resectable extrahepatic cholangiocarcinoma with biliary obstruction, it remains a controversy whether to choose percutaneous transhepatic biliary drainage (PTBD) or endoscopic biliary drainage (EBD). A systematic review was conducted to compare the long-term efficacy between the two techniques. Materials and Methods: Eligible studies were searched from January 1990 to May 2018, comparing the long-term efficacy between EBD and PTBD for extrahepatic cholangiocarcinoma. Primary end point was overall survival (OS) rate, and secondary end points included postoperative severe complications and seeding metastasis. Effect size on outcomes was calculated using a fixed- or random-effect model, accompanied with hazard ratio (HR) and 95% confidence interval (CI). Result: Six studies were included in this meta-analysis. Meta-analysis showed that EBD was superior to PTBD in OS (HR = 0.70, 95% CI 0.59–0.84,P= 0.0002). But subgroup results showed that the superiority disappeared in distal cholangiocarcinoma (HR = 0.76, 95% CI 0.56–1.01,P= 0.06). Other prognostic factors such as intraoperative blood transfusion, lymphatic metastasis and seeding metastasis, were inconsistent between groups. In addition, regional disparity was obviously apparent between Japanese and non-Japanese studies. Conclusion: The conclusion that EBD was superior to PTBD in OS for resectable extrahepatic cholangiocarcinoma with biliary obstruction is less convincing, and more trials need to be conducted in future.