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Background: Patients with isolated IgG4-related sclerosing cholangitis (IgG4-SC) often undergo unnecessary resection. The aim of this study was to validate the revised Japanese diagnostic criteria for isolated IgG-4-SC and to improve awareness about this condition in the population., Methods: This was a Japanese retrospective multicenter study. We focused on the data and diagnostic yield obtained using the Japanese diagnostic criteria published initially in 2012 and revised later in 2020 for the diagnosis of isolated IgG4-SC., Results: Patients with isolated IgG4-SC could be classified into two groups based on the primary location of the lesion: the hilar type (n = 40) and the extrahepatic type (n = 13). In total, 10 patients with the hilar type had undergone unnecessary resection. The revised 2020 criteria are useful for the diagnosis of extrahepatic lesions, which are not included in the 2012 criteria. The need for a steroid trial was reduced from 37.7% when the diagnosis was based on the 2012 criteria to 7.6% when the diagnosis was based on the revised 2020 criteria. The diagnostic specificity also improved from 58.5% for the 2012 criteria to 88.7% for the revised 2020 criteria., Conclusion: Our validation of the 2020 criteria for the diagnosis of IgG4-SC could contribute to avoiding unnecessary resection in patients with isolated IgG4-SC, which can be classified into the hilar and extrahepatic types. The 2020 criteria can enhance the diagnosis rate of isolated IgG4-SC and uncover this tough-to-diagnose entity based on inclusion of the imaging findings and decrease the dependence on a steroid trial., (© 2024 Japanese Society of Hepato‐Biliary‐Pancreatic Surgery.)

Background: Although intraductal plastic stent (IS) placement is an effective treatment for unresectable malignant hilar biliary obstruction (UMHBO), the effectiveness of unilateral and bilateral IS drainage remains controversial. This retrospective study investigated the effectiveness of bilateral IS placement for UMHBO using the propensity score matching method., Methods: Patients who underwent transpapillary endoscopic stenting for UMHBO were analyzed for technical and clinical success, adverse events, and time to recurrent biliary obstruction (TRBO)., Results: A total of 321 patients were enrolled in the study with 27 patients in each unilateral and bilateral IS group in the propensity score-based cohort. Technical success was 100%, while clinical success was 93% and 96% in the unilateral and bilateral IS groups, respectively (p = 1.0). Cholecystitis occurred in 4% and 7%, respectively (p = 1.0). The median TRBO was shorter in the unilateral group (129 [5-383] days) than that in the bilateral group (226 [16-563] days) (p = .0281). Bilateral IS placement was an independent long TRBO factor (hazard ratio [HR] 0.46; 95% confidence interval [CI]: 0.21-0.97; p = .041)., Conclusions: Unilateral and bilateral IS placement had high technical and clinical success rates in primary stent placement. However, bilateral IS placement showed a longer TRBO. Bilateral IS placement may be a good option for initial UMHBO drainage., (© 2023 Japanese Society of Hepato‐Biliary‐Pancreatic Surgery.)

Background: One-stage endoscopic management, where papillary interventions and stone removal are simultaneously performed, has been reported to be an effective treatment for acute cholangitis caused by common bile duct stones (CBDS). However, there have been few reports comparing it with two-stage management, and there is no established strategy for the indication of one-stage management. The aim of the present study was to compare the short- and long-term outcomes between one- and two-stage management for acute cholangitis caused by CBDS., Methods: We retrospectively studied 577 patients who underwent one- or two-stage endoscopic management for acute cholangitis between May 2010 and December 2020. The patients were divided into one- and two-stage groups by endoscopic management. The clinical outcomes were compared between groups., Results: The technical and clinical success were similar in both groups, although the length of hospital stay was significantly shorter in the one-stage group. Although there was no difference in the early adverse event (AE) between two groups, post-ERCP pancreatitis was recognized in 3.4% and 10.0%, which was significantly higher in the two-stage group. The cumulative late AE rate was 22.6% and 14.1%, which was significantly higher in the one-stage group. In the multivariate analyses, intervention (one-stage), number of CBDS ≥2, biliary drainage, the use of ML, and gallbladder stone were identified as significant factors associated with the recurrence of CBDS., Conclusion: Although one-stage endoscopic management is useful and safe with reducing hospital stays, diligent postoperative follow-up with consideration to recurrence of CBDS is essential., (© 2024 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: Endoscopic transpapillary naso-gallbladder drainage (ENGBD) has been reported to be an effective treatment option for acute cholecystitis. At our institution, ENGBD was first placed for external fistula management, and endoscopic internalization by cutting was performed, shifting to endoscopic transpapillary gallbladder stenting (EGBS) after improvement of cholecystitis. However, there has been no comparative study to define which preoperative management is better: converting ENGBD to EGBS or removing ENGBD. The study aimed to compare the incidence rate of the late adverse events (AEs) related to biliary system between shifting from ENGBD to EGBS and removal of ENGBD., Methods: We retrospectively studied 122 patients who underwent ENGBD for acute cholecystitis between January 2010 and October 2022. The patients were divided into two groups: the cutting group (converting ENGBD to EGBS) and the removal group (removal of ENGBD). The short and late clinical outcomes were compared between groups., Results: Endoscopic transpapillary naso-gallbladder drainage was successfully placed in 78.6% (96/122), and elective cholecystectomy was performed in 31 and 36 patients in the cutting and removal groups, respectively. The cumulative late-AE rates were 6.4% and 33.3% (p = .007), with a median waiting period for elective cholecystectomy of 58 and 33 days (p = .390) in the cutting and removal groups, respectively. In the multivariate analysis, only endoscopic internalization by cutting was an independent factor affecting late AEs., Conclusion: Endoscopic internalization by cutting ENGBD after the resolution of acute cholecystitis was considered effective in reducing the risk of late AEs during the waiting period for an elective cholecystectomy., (© 2023 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: Endoscopic ultrasound-guided antegrade treatment (EUS-AG) and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) have emerged as useful procedures for managing bile duct stones (BDS) in patients with surgically altered anatomy. However, the comparison between these two procedures has not been well studied. The aim of our study was to compare the clinical outcomes of EUS-AG and BE-ERCP for managing BDS in patients with surgically altered anatomy., Methods: The database was retrospectively evaluated at two tertiary care centers to identify patients with surgically altered anatomy who underwent either EUS-AG or BE-ERCP for BDS. Clinical outcomes were compared between the procedures. The success rate of each procedure was evaluated in three steps: endoscopic approach, biliary access, and stone extraction., Results: Among the 119 identified patients, 23 had EUS-AG, and 96 had BE-ERCP. The overall technical success rates of EUS-AG and BE-ERCP were 65.2% (15/23) and 69.8% (67/96), respectively (P = .80). The comparison of each step between the procedures EUS-AG versus BE-ERCP was as follows: endoscopic approach, 100% (23/23) versus 88.5% (85/96) (P = .11); biliary access, 73.9% (17/23) versus 80.0% (68/85) (P = .57); stone extraction, 88.2% (15/17) versus 98.5% (67/68) (P = .10). The overall adverse event rate was 17.4% (4/23) versus 7.3% (7/96) (P = .22)., Conclusions: Both EUS-AG and BE-ERCP are effective and relatively safe procedures in the management of BDS in patients with surgically altered anatomy. The challenging steps of each procedure might be different, which could help decide which one to use to manage BDS in patients with surgically altered anatomy., (© 2023 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: During endoscopic ultrasound-guided biliary drainage (EUS-BD), a combination of a 19-gauge needle and a 0.025-inch guidewire is generally used. However, a 19-gauge needle has poor maneuverability because of their stiffness and rigidity and might have poor penetrability in non-dilated bile ducts because of their large bore. In contrast, the application of a 22-gauge needle is expected to have improved maneuverability. However, only a 0.018-inch guidewire, which has less supportability, is applicable in the subsequent guidewire selection. This study aimed to evaluate the feasibility and safety of a dedicated bougie dilator for a 0.018-inch guidewire., Methods: From September 2019 to May 2020, 26 patients underwent fistula dilation using the dilator after accessing the bile duct using a 22-gauge needle and a 0.018-inch guidewire during EUS-BD. The success and adverse event rates of EUS-BD were evaluated., Results: Biliary access with a combination of a 22-gauge needle and a 0.018-inch guidewire was successful in all with a median bile duct diameter of 5 mm. Dilation of the fistula using the dedicated dilator was also successful in all cases. Subsequently, the dilator was successfully exchanged to an ERCP catheter that allowed for exchange to a 0.025-inch guidewire, except in one case where the catheter did not cross the fistula and a dilation balloon was inserted for an exchange to a 0.025-inch guidewire. The technical success rate of the EUS-BD was 100%. The adverse event rate was 19%., Conclusion: The application of the dedicated dilator for a 0.018-inch guidewire was considered feasible and safe for EUS-BD., (© 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background/purpose: This study aimed to evaluate the feasibility of endoscopic ultrasound (EUS)-guided antegrade covered stent placement with long duodenal extension (EASL) for malignant distal biliary obstruction (MDBO) with duodenal obstruction (DO) or surgically altered anatomy (SAA) after failed endoscopic retrograde cholangiopancreatography (ERCP)., Methods: Outcomes were technical and clinical success, reintervention rate, adverse events, stent patency, and overall survival. Inverse probability of treatment weighting (IPTW) and competing-risk analysis were performed to compare with conventional EUS-BD., Results: Twenty-five patients (DO, n = 18; SAA, n = 7) were included. The technical and clinical success rates were 96% and 84%, respectively. Reintervention occurred in two patients (8.3%). Adverse events occurred in six patients (24%; two cholangitis, 16%; four mild postprocedural pancreatitis [24% (n = 4/17) in patients with non-pancreatic cancers]). The median patency was 9.4 months, and the overall survival was 2.73 months. After IPTW adjustment, the median patency in the EASL (n = 25) and conventional EUS-BD (n = 29) were 10.1 and 6.5 months, respectively (P = .018)., Conclusions: EASL has acceptable clinical outcomes with a low reintervention rate but higher rate of postprocedural pancreatitis in patients with non-pancreatic cancers. Randomized trials comparing EASL and conventional EUS-BD for MDBO with pancreatic cancers and DO/SAA after failed ERCP are needed to validate our findings., (© 2021 The Authors. Journal of Hepato-Biliary-Pancreatic Sciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: Endoscopic transpapillary gallbladder drainage (EGBD) has been reported as an effective gallbladder drainage treatment option for acute cholecystitis in high-risk surgical patients. However, the long-term outcomes such as cholecystitis' recurrence rate after placement of EGB stenting (EGBS) have not been well studied yet., Aims: The aim of the present study was to compare the long-term outcome of EGBS and removal of gallbladder drainage after percutaneous transhepatic gallbladder drainage (PTGBD) or endoscopic nasogallbladder drainage (ENGBD) for acute cholecystitis in high-risk surgical patients and clarify the usefulness of long-term placement of EGBS., Methods: We retrospectively studied 180 high-risk surgical patients with acute cholecystitis between January 2010 and December 2018. The patients were divided into two groups: EGBS group (long-term placement of EGBS) or Removal group (removal of drainage tube after PTGBD or ENGBD). Clinical outcomes, including long-term results, were compared between the groups., Results: The cumulative late adverse event (AE) rates were 5.0% and 22.1% in the EGBS and Removal group (P = .002), with a median follow-up period of 375 and 307 days in the two groups, respectively. The cumulative cholecystitis recurrence rate was 5.0% (2/40) in the EGBS group and 16% (21/131) in the Removal group (P = .024), respectively. In the multivariate analysis for late AE, only EGBS was an independent risk factor with a decreasing value., Conclusion: The permanent EGBS in high-risk surgical patients with acute cholecystitis was considered effective in reducing the risk of late AE., (© 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background/purpose: Unresectable distal malignant biliary obstruction (DMBO) in patients with surgically altered anatomy is traditionally managed with percutaneous transhepatic biliary drainage (PTBD) and stenting because the anatomical features complicate the endoscopic approach to the biliary orifice. EUS-guided approaches recently emerged as alternative treatments; however, limited data comparing the procedures are available. The aim of this study was to compare EUS-antegrade biliary stenting (ABS) with PTBD for DMBO in patients with surgically altered anatomy., Methods: The medical records of patients who underwent EUS-ABS or PTBD for the management of DMBO and had a history of upper intestinal surgery at two tertiary centers between 2007 and 2019 were retrospectively evaluated. The study outcomes were technical, clinical, and internalization success rates and adverse event rates., Results: Of the 64 enrolled patients, 35 underwent EUS-ABS and 29 had PTBD. Basic characteristics including age, sex, performance status, primary malignancy, and reconstruction method did not differ significantly between groups. The technical, clinical, and internalization success rates in the EUS-ABS and PTBD groups were 97.1% vs 96.6% (P = 1.00), 97.1% vs 93.1% (P = .586), and 97.1% vs 75.9% (P = .01), respectively. The adverse event rate was 11.4% vs 27.6% (P = .119). No significant long-term difference was seen in time to recurrent biliary obstruction and survival. Multivariate analysis confirmed EUS-ABS was not an independent risk factor for survival., Conclusions: Similar to PTBD, EUS-ABS can effectively and safely manage DMBO in patients with surgically altered anatomy. Further well-designed trials are warranted to confirm these findings., (© 2020 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background/purpose: Endoscopic transpapillary gallbladder drainage (ETGBD), including endoscopic nasogallbladder drainage (ENGBD) and endoscopic gallbladder stenting (EGBS), has been reported to be an effective treatment for acute cholecystitis. However, ETGBD is considered to be more difficult than percutaneous transhepatic gallbladder drainage (PTGBD), and few studies have evaluated the factors that affect technical success of the procedure. We investigated the factors predicting its technical success from among patient characteristics and image findings before treatment., Methods: Three hundred twenty three patients who underwent ETGBD for acute cholecystitis from November 2006 to December 2018 were analyzed retrospectively., Results: The technical success rate was 72.8% (235/323). The technical success rate by cystic duct direction was as follows: proximal/distal, 65.9%/93.6%; right/left: 74.0%/65.2%; cranial/caudal, 83.5%/20.0%. The clinical response rate was 96.2% (226/235). Adverse events were encountered in 5.9% of cases (19/323), including cystic duct injury (11 patients), pancreatitis (five patients), and bleeding (three patients). In both univariate and multivariate analysis, presence of cystic duct stone, dilation of the common bile duct (CBD), and cystic duct direction (proximal and caudal branches) were identified as significant factors affecting technical failure of ETGBD., Conclusion: Although ETGBD was an effective and safe procedure for acute cholecystitis, it has a limited success rate. The presence of cystic duct stone, dilation of CBD, and cystic duct direction (proximal and caudal branches) can serve as important predictors of ETGBD difficulties. These findings should be considered before procedures and the necessary adaptation of ETGBD made., (© 2020 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Endoscopic ultrasound/ultrasonography-guided biliary drainage (EUS-BD) is a relatively new modality for biliary drainage after failed or difficult transpapillary biliary cannulation. Despite its clinical utility, EUS-BD can be complicated by severe adverse events such as bleeding, perforation, and peritonitis. The aim of this paper is to provide practice guidelines for safe performance of EUS-BD as well as safe introduction of the procedure to non-expert centers. The guidelines comprised patient-intervention-comparison-outcome-formatted clinical questions (CQs) and questions (Qs), which are background statements to facilitate understanding of the CQs. A literature search was performed using the PubMed and Cochrane Library databases. Statement, evidence level, and strength of recommendation were created according to the GRADE system. Four committees were organized: guideline creation, expert panelist, evaluation, and external evaluation committees. We developed 13 CQs (methods, device selection, supportive treatment, management of adverse events, education and ethics) and six Qs (definition, indication, outcomes and adverse events) with statements, evidence levels, and strengths of recommendation. The guidelines explain the technical aspects, management of adverse events, and ethics of EUS-BD and its introduction to non-expert institutions., (© 2019 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: Bilateral self-expandable metallic stent (SEMS) placement is effective for long-term management of unresectable malignant hilar biliary obstruction (UMHBO). However, endoscopic reintervention (ERI) for bilateral SEMSs is not well-studied. This study aimed to evaluate ERI efficacy after stent-in-stent placement., Methods: Data of 31 patients who underwent ERI from May 2000 to July 2018 were analyzed., Results: The technical success rate was 80.7% (25/31) and no adverse events occurred. The functional success rate was 100% (25/25). In a multivariate logistic regression analysis, the angle between the bilateral SEMSs (ABBS) >104° (odds ratio 50.49, 95% CI 3.370-2131, P = 0.0039) and overgrowth (odds ratio 25.70, 95% CI 1.121-1234, P = 0.0423) were risk factors for ERI failure. Multiple liver metastases, which sometimes cause overgrowth, were also risk factors. After ERI, some patients underwent additional SEMS (n = 4), plastic stent (n = 14) placement, or internal cleaning of the initial SEMS alone (n = 7). There were no significant intergroup differences in the 50% time to recurrent biliary obstruction., Conclusions: ABBS >104° and overgrowth were risk factors for ERI failure after stent-in-stent placement. In the decision-making process for initial SEMS placement for UMHBO, patient condition should be considered, including the angle between bilateral bile ducts and multiple liver metastases., (© 2019 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: Endoscopic retrograde cholangiopancreatography (ERCP) for management of bile duct stone (BDS) in patients with surgically altered anatomy is challenging even when applying enteroscopy. Endoscopic ultrasound-guided antegrade treatments (EUS-AG) for BDS have been developed but have not been well studied yet. The aim of the present study was to evaluate the feasibility and safety of EUS-AG for BDS in patients with surgically altered anatomy as a multicenter retrospective cohort study., Methods: A retrospective database analysis was performed to identify patients with surgically altered anatomy who underwent EUS-AG for the management of BDS at four academic care centers. Basic characteristics of the patients and details of the procedures were determined and the success rates and adverse event rates were evaluated., Results: EUS-AG for BDS was attempted in 29 patients. Successful BDS removal was achieved in 72% (21/29) of patients. Reasons for failed EUS-AG were unsuccessful bile duct puncture in six, unsuccessful guidewire manipulation in one, and unsuccessful stone removal using a retrieval balloon in one. Adverse events occurred in five (17%) but were successfully managed conservatively., Conclusion: EUS-AG for BDS is a feasible and safe alternative in patients with surgically altered anatomy, although further evaluation and development of dedicated devices are needed., (© 2016 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Recently, endoscopic ultrasonography (EUS)-guided transhepatic antegrade interventions have been introduced in patients with a surgically altered anatomy. Herein, we focused on and reviewed EUS-guided transhepatic antegrade stone removal (EUS-TASR) in patients with a surgically altered anatomy and native papilla. The basic technique of EUS-TASR involves the following steps: (1) EUS-guided needle puncture; (2) guidewire placement; (3) tract dilation; (4) balloon sphincteroplasty; (5) stone removal; and (6) stent placement if needed. Based on reports in the literature including our cases, the complete stone extraction rate is 71.4% (10/14) including five of our cases (60% success rate) at one session without serious complications. In conclusion, EUS-TASR appears to be feasible and useful in selected patients although its application may be limited depending on anatomical factors and current devices used., (© 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is a well-established procedure for diagnosis of pancreatic solid masses. This technique is highly accurate and safe and can be performed uneventfully in most cases. However, factors such as unstable scope position, inappropriate location of the lesion, lesion mobility, and lesion characteristics may complicate the procedure. To overcome such difficulties, it is necessary to select the most suitable needle and consider several technical points according to each situation. We introduce our standard technique for EUS-FNA and provide several tips for ensuring a successful procedure., (© 2013 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: Endoscopic biliary stenting is a well-established palliative treatment for unresectable malignant biliary strictures, for which plastic tube stents (PSs) and self-expandable metallic stents (SEMSs) are most commonly used. The efficacy of these stents has been extensively described in distal biliary strictures, but not in hilar biliary strictures. The present study aimed to compare the efficacy of PSs and SEMSs for unresectable malignant hilar biliary strictures., Methods: From June 2004 to November 2008, 60 patients were enrolled and prospectively randomized into the PS or SEMS group., Results: The 6-month patency rate was significantly higher in the SEMS group than in the PS group (81 vs. 20%; p = 0.0012). Kaplan-Meier analysis showed significantly longer patency in the SEMS group than in the PS group (p = 0.0002); the 50% patency period was 359 days in the SEMS group and 112 days in the PS group. There was no significant difference in the overall survival period between the PS and SEMS groups (p = 0.2834). The mean number of reinterventions for stent failures was significantly lower in the SEMS group (0.63 times/patient) than in the PS group (1.80 times/patient) (p = 0.0008). The overall total cost for the treatment was significantly lower in the SEMS group than in the PS group (p = 0.0222)., Conclusions: SEMSs were associated with a longer patency than PSs in patients with unresectable hilar biliary stricture. SEMSs were also more advantageous in reducing the number of reintervention sessions and the overall treatment cost.

Background: Various types of self-expandable metallic stents (SEMSs) are commercially available. However, few reports have compared the performance of the various SEMSs. In addition to long-term patency, maneuverability during initial placement and feasibility of re-intervention for the stent occlusion are also very important., Methods: In this retrospective analysis, we compared the duration of stent patency and frequency of re-interventions in 96 patients diagnosed with unresectable hilar biliary strictures in whom initial 10-mm SEMSs were inserted between June 1999 and November 2008., Results: Based on Kaplan-Meier curves, significantly shorter patency duration was noted for SEMSs with moderate axial force (AF) than for other groups of SEMSs with low AF. Endoscopic re-interventions for SEMS occlusion were easier in a group of SEMSs with low AF and large cell width than in other groups of SEMSs., Conclusions: With respect to patency duration and the frequency of re-intervention required, we consider that SEMSs with low AF and large cell width are favorable for hilar biliary strictures.