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Background/Aims: Endoscopic papillary balloon dilation (EPBD) is a possible alternative to endoscopic sphincterotomy (EST) for common bile duct (CBD) stones. To date, 10‑ and 8‑mm EPBD have not been fully compared. Patients and Methods: Patients who underwent EPBD for CBD stones at two Japanese tertiary care centers between May 1994 and January 2014 were identified. Matched pairs with 10‑ and 8‑mm EPBD were generated. Short‑ and long‑term outcomes were compared between the two groups. Results: A total of 869 patients were identified (61 and 808 patients for 10‑ and 8‑mm EPBD, respectively), and 61 well‑balanced pairs were generated. The rate of complete stone removal within a single session was higher in the 10‑mm EPBD group than in the 8‑mm EPBD group (69% vs. 44%, P < 0.001), and use of lithotripsy was less frequent in the 10‑mm EPBD group (23% vs. 56%, P < 0.001). The rates of post‑ERCP pancreatitis were similar between the 10‑ and 8‑mm EPBD groups (11% vs. 8%). Cumulative biliary complication‑free rates were not statistically different between the two groups: 88% [95% confidence interval (CI): 79-97%] and 94% (95% CI: 88-100%) at 1 year and 69% (95% CI: 56-85%) and 80% (95% CI: 69-93%) at 2 years in the 10‑ and 8‑mm EPBD groups, respectively. In the 10‑mm EPBD group, ascending cholangitis was not observed, and pneumobilia was found in 5% of cases during the follow‑up period. Conclusions: EPBD using a 10‑mm balloon for CBD stones is safe and more effective than 8‑mm EPBD. The sphincter function is highly preserved after 10‑mm EPBD. [ABSTRACT FROM AUTHOR]

Background and study aims: There are no guidelines for the timing of conversion from a singleguidewire to a double-guidewire technique to facilitate selective bile duct cannulation and reduce post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), when using wireguided cannulation. We investigated whether early conversion to the double-guidewire method, at first unintentional insertion of a guidewire into the pancreatic duct, facilitated selective bile duct cannulation and reduced PEP compared with repeated single-guidewire attempts. Patients and methods: A multicenter prospective randomized controlled trial included 274 patients with a naive papilla, undergoing endoscopic retrograde cholangiography (ERC) using wireguided cannulation in whom there was unintentional insertion of the guidewire into the pancreatic duct. With the guidewire still in the duct, patients were randomly assigned to undergo the double-guidewire technique or repeated singlewire cannulation. Main outcomes were success rates for selective bile duct cannulation and PEP frequency. Results: Success rates for selective bile duct cannulation within 10 attempts and 10 minutes were 75% and 70%, respectively, for the early double- guidewire (EDG) and repeated single-guidewire (RSG) cannulation groups (relative rate 1.07, 95% confidence interval [95 %CI] 0.93-1.24, P= 0.42). Corresponding final selective bile duct cannulation rates were 98% and 97% (relative rate 1.01, 95%CI 0.97-1.05, P=1.00). PEP rates were 20% and 17%, respectively, for the EDG and RSG cannulation groups (relative risk 1.17, 95%CI 0.71-1.94, P=0.53). Double-guidewire cannulation was more effective in patients with malignant biliary stricture (relative rate 1.36, 95%CI 1.05-1.77, P=0.02). Conclusions: During therapeutic ERC using wire guided cannulation, converting to a double-guidewire technique neither facilitated selective bile duct cannulation nor decreased PEP incidence compared with repeated use of a single-wire technique. [ABSTRACT FROM AUTHOR]

Background/Aims: To determine the nutritional markers important for assessing the degree of pancreatic insufficiency due to chronic pancreatitis in routine clinical practice. Methods: A total of 137 patients with chronic pancreatitis were followed up for more than 1 year. They were divided into two groups: a pancreatic diabetes mellitus (DM) group, consisting of 47 patients undergoing medical treatment for DM of pancreatic origin, and a nonpancreatic DM group, consisting of 90 other patients (including 86 patients without DM). Serum albumin, prealbumin, total cholesterol, cholinesterase, magnesium, and hemoglobin were compared between the two groups. Results: The total cholesterol was significantly lower in the pancreatic than the nonpancreatic DM group (164 mg/dL vs 183 mg/dL, respectively; p=0.0028). Cholinesterase was significantly lower in the former group (263 U/L vs 291 U/L, respectively; p=0.016). Among the 37 patients with nonalcoholic pancreatitis, there was no difference in the cholinesterase levels between the pancreatic and nonpancreatic (296 U/L vs 304 U/L, respectively; p=0.752) DM groups, although cholesterol levels remained lower in the former (165 mg/dL vs 187 mg/dL, respectively; p=0.052). Conclusions: Cholinesterase levels are possibly affected by concomitant alcoholic liver injury. The total cholesterol level should be considered when assessing pancreatic insufficiency due to chronic pancreatitis. [ABSTRACT FROM AUTHOR]

Background/Aims: Stent migration occurs frequently, but the prevention of complications resulting from covered self-expandable metal stents (C-SEMSs) remains unresolved. We prospectively assessed a newly developed C-SEMS, a modified covered Zeo stent (m-CZS), in terms of its antimigration effect. Methods: Between February 2010 and January 2011, an m-CZS was inserted into 42 patients (31 initial drainage cases and 11 reintervention cases) at a tertiary referral center and three affiliated hospitals. The laser-cut stent was flared for 1.5 cm at both ends, with a 1 cm raised bank located 1 cm in from each flared end. The main outcome of this study was the rate of stent migration, and secondary outcomes were the rate of recurrent biliary obstruction (RBO), the time to RBO, the frequencies of complications, and overall survival. Results: Of the 31 patients with initial drainage, stent migration occurred in four (12.9%, 95% confidence interval, 5.1% to 29.0%), with a mean time of 131 days. RBO occurred in 18 (58%), with a median time to RBO of 107 days. Following previous C-SEMS migration, seven of 10 patients (70%) did not experience m-CZS migration until death. Conclusions: m-CZSs with antimigration properties effectively, although not completely, prevented stent migration after stent insertion. [ABSTRACT FROM AUTHOR]

Abstract  In the endoscopic management of unresectable malignant biliary obstructions by placement of a metallic stent (MS), longer patency and a lower incidence of stent occlusion are desirable goals. With its mesh structure, the uncovered MS (UMS) is occluded mainly by tumor or tissue ingrowth, making it impossible to remove. The covered MS (CMS) was developed to overcome these disadvantages, and was shown to maintain patency longer than the UMS in our randomized study. The most important characteristic of the CMS is that it is removable, allowing it to be used in patients with resectable malignancies and benign strictures. In addition, the drug-eluting CMS provides an additional approach to the treatment of biliary malignancies. The CMS may also change the treatment paradigm for biliary strictures and strictures due to chronic pancreatitis. The CMS is analogous to a large-bore, expandable plastic stent and is effective both as an endoprosthesis and a dilating or anti-cancer device. However, to better understand the utility of these devices, we need to first consider mechanical properties such as radial force (RF, expansion force) and axial force (AF, straightening force). AF is particularly important when developing CMSs because of related complications. [ABSTRACT FROM AUTHOR]

Abstract  Endoscopists seek to conduct more aggressive surgical procedures that surpass the limitations of existing endoscopic procedures. Endoscopic pancreatic necrosectomy and natural orifice transluminal endoscopic surgery (NOTES) are typical examples of this new trend; both are performed through the gastrointestinal wall without a skin incision. Endoscopic necrosectomy is effective for managing organized pancreatic necrosis and abscesses. The necrotic tissues are removed endoscopically by directly entering the cavity of the organized pancreatic necrosis. NOTES is a possible advance over surgical intervention, as it is a less invasive, more cosmetic, and effective procedure. There are various approaches, including the esophagus, stomach, colon, and vagina; Various procedures are possible using NOTES, such as cholecystectomy, appendectomy, full-thickness stomach resection, splenectomy, gastrointestinal (GI) anastomosis, and peritoneoscopy. The requirements for NOTES include high proficiency in endoscopic techniques, including knowledge of various devices, anatomy, and surgical procedures. Since most GI endoscopists have no surgical background, to increase the usage of NOTES, GI endoscopists should form and lead teams that include various specialists. We believe that endoscopic necrosectomy and NOTES represent a major shift in the treatment paradigm because physicians can treat beyond the gastrointestinal wall and endoscopic procedures will replace surgical treatment. [ABSTRACT FROM AUTHOR]

Abstract  Pancreatic tuberculosis (TB) is a rare condition that is sometimes difficult to differentiate from pancreatic cancer or other malignancies. A 75-year-old man was admitted to our hospital because of weight loss, fever, and diarrhea. Abdominal ultrasonography and computed tomography (CT) revealed a 3-cm mass in the pancreas head with abdominal lymphadenopathy. Endoscopic retrograde cholangiopancreatography did not show pancreatic duct stenosis or dilatation, but a pancreaticobiliary fistula was demonstrated. Cytological and bacteriological examinations of the pancreatic juice and bile were negative. Endoscopic ultrasonography-guided fine needle aspiration of the mass was not diagnostic. Colonoscopic features and biopsy specimens affirmed the diagnosis of TB, and treatment with antitubercular drugs was started. The pancreatic mass disappeared within 8 weeks and the pancreaticobiliary fistula resolved. [ABSTRACT FROM AUTHOR]

Background/Aims: The optimal length of the uncovered portion of partially covered self-expandable metal stents (PCSEMSs) used in endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) remains unclear. This study investigated the safety and efficacy of PCSEMSs with different uncovered lengths, with a focus on stent migration and time to recurrent biliary obstruction (RBO). Methods: Outcomes of patients undergoing EUS-HGS using PCSEMSs with 5-mm and 20-mm uncovered portions at our institution from January 2016 to December 2021 were compared. Results: Sixty-two patients underwent EUS-HGS using PCSEMS (5/20-mm uncovered portions: 32/30). Stent migration occurred only in the 5-mm group. There were no differences in RBO rates (28.1% vs. 40.0%) or median time to RBO (6.8 vs. 7.1 months) between the two groups. Median overall survival (OS) was longer in the 20-mm group (3.1 vs. 4.9 months, p=0.037) due to the higher number of patients that resumed chemotherapy after EUS-HGS (56.7% vs. 28.1%, p=0.029). Good performance status, absence of hepatic metastases, and chemotherapy after EUS-HGS were independent predictors of longer OS. Conclusions: No migration was observed in patients treated with PCSEMS with 20-mm uncovered portions. Patients treated with PCSEMS with 20-mm uncovered portions performed at least as well as those treated with 5-mm uncovered portions in all material respects. [ABSTRACT FROM AUTHOR]

Background/Aims: Hepaticojejunostomy anastomotic stricture (HJAS) is a feared adverse event associated with hepatopancreatobiliary surgery. Although balloon dilation for benign HJAS during endoscopic retrograde cholangiopancreatography with balloon-assisted enteroscopy has been reported to be useful, the treatment strategy remains controversial. Therefore, we evaluated the outcomes and risk factors of recurrent stenosis after balloon dilation alone for benign HJAS. Methods: We retrospectively analyzed consecutive patients who underwent balloon-assisted enteroscopy-endoscopic retrograde cholangiopancreatography for benign HJAS at our institution between July 2014 and December 2020. Results: Forty-six patients were included, 16 of whom had recurrent HJAS after balloon dilation. The patency rates at 1 and 2 years after balloon dilation were 76.8% and 64.2%, respectively. Presence of a residual balloon notch during balloon dilation was an independent predictor of recurrence (hazard ratio, 2.80; 95% confidence interval, 1.01-7.78; p=0.048), whereas HJAS within postoperative 1 year tended to be associated with recurrence (hazard ratio, 2.43; 95% confidence interval, 0.85-6.89; p=0.096). The patency rates in patients without a residual balloon notch were 82.1% and 73.1% after 1 and 2 years, respectively. Conclusions: Balloon dilation alone may be a viable option for patients with benign HJAS without residual balloon notches on fluoroscopy. [ABSTRACT FROM AUTHOR]

Background/Aims: Selective bile duct or pancreatic duct cannulation remains a significant initial hurdle in endoscopic retrograde cholangiopancreatography (ERCP) despite advances in endoscopy and accessories. This study evaluated our experience with a rotatable sphincterotome in cases of difficult cannulation. Methods: We retrospectively reviewed ERCP cases using TRUEtome, a rotatable sphincterotome, as a rescue device for cannulation at a cancer institute in Japan from October 2014 to December 2021. Results: TRUEtome was used in 88 patients. Duodenoscopes were used for 51 patients, while single-balloon enteroscopes (SBE) were used for 37 patients. TRUEtome was used for biliary and pancreatic duct cannulation (84.1%), intrahepatic bile duct selection (12.5%), and strictures of the afferent limb (3.4%). Cannulation success rates were similar in the duodenoscope and SBE groups (86.3% vs. 75.7%, p=0.213). TRUEtome was more commonly used in cases with steep cannulation angles in the duodenoscope group and in cases requiring cannulation in different directions in the SBE group. There were no significant differences in adverse events between the two groups. Conclusions: The cannulation sphincterotome was useful for difficult cannulations in both unaltered and surgically altered anatomies. It may be an option to consider before high-risk procedures such as precut and endoscopic ultrasound-guided rendezvous techniques. [ABSTRACT FROM AUTHOR]

Background/Aims: Mechanical properties (MPs) and axial and radial force (AF and RF) may influence the efficacy and complications of self-expandable metallic stent (SEMS) placement. We measured the MPs of various SEMSs and examined their influence on the SEMS clinical ability. Methods: We evaluated the MPs of 29 types of 10-mm SEMSs. RF was measured using a conventional measurement device. AF was measured using the conventional and new methods, and the correlation between the methods was evaluated. Results: A high correlation in AFs was observed, as measured by the new and conventional manual methods. AF and RF scatterplots divided the SEMSs into three subgroups according to structure: hook-and-cross-type (low AF and RF), cross-type (high AF and low RF), and laser-cut-type (intermediate AF and high RF). The hook-and-cross-type had the largest axial force zero border (>20°), followed by the laser-cut and cross types. Conclusions: MPs were related to stent structure. Hook-and-cross-type SEMSs had a low AF and high axial force zero border and were considered safest because they caused minimal stress on the biliary wall. However, the increase in RF must be overcome. [ABSTRACT FROM AUTHOR]

Background/Aims: Digital single-operator cholangioscopy (DSOC)-guided mapping biopsy (DMB) and tube-assisted mapping biopsy (TMB) are two techniques used for preoperative evaluation of biliary tract cancer (BTC). However, data regarding the diagnostic performance of these techniques are limited. Methods: We retrospectively examined consecutive patients with BTC who underwent either technique at our institution between 2018 and 2020. We evaluated the technical success rate, adequate tissue acquisition rate, and diagnostic performance of these techniques for the evaluation of lateral spread of BTC. Results: A total of 54 patients were included in the study. The technical success rate of reaching the target sites was 95% for DMB and 100% for TMB. The adequate tissue acquisition rate was 61% for DMB and 69% for TMB. The adequate tissue acquisition rate was low, especially for target sites beyond the secondary biliary radicles. The sensitivity of DMB alone was 39%, which improved to 65% when combined with visual impression. Experts demonstrated a higher negative predictive value and diagnostic accuracy with respect to both DSOC visual impression and DMB for the evaluation of lateral spread of BTC compared to trainees. Conclusions: Adequate tissue acquisition rates were similar between the two techniques. Since DMB requires expertise, TMB may be an acceptable option when DSOC is unavailable or when DSOC expertise is limit [ABSTRACT FROM AUTHOR]

Background/Aims: Several fine-needle biopsy (FNB) needles are available for endoscopic ultrasound (EUS)-guided tissue acquisition. However, there is disagreement on which type of needle has the best diagnostic yield. The aim of this study was to compare the performance and safety of two commonly used EUS-FNB needles. Methods: We retrospectively analyzed consecutive patients who underwent EUS-FNB between June 2016 and March 2020 in our hospital. Two types of needles were evaluated: a 20-gauge Menghini needle with a lateral forward bevel and a 22-gauge Franseen needle. Rapid on-site evaluation was performed in all the cases. A multivariate analysis was performed to clarify the negative predictive factors for obtaining a histological diagnosis. Propensity score matching was performed to compare the diagnostic yields of these two needles. Results: We analyzed 666 patients and 690 lesions. The overall diagnostic rate of histology alone was 88.8%, and the overall adverse event rate was 1.5%. Transduodenal access and small lesions (≤2 cm) were identified as negative predictive factors for obtaining a histological diagnosis. After propensity score matching, 482 lesions were analyzed. The diagnostic accuracy rates of histology in the M and F needle groups were 89.2% and 88.8%, respectively (p=1.00). Conclusions: Both the needles showed high diagnostic yield, and no significant difference in performance was observed between the two. [ABSTRACT FROM AUTHOR]

Aim: To determine the optimal method of endoscopic preoperative biliary drainage for malignant distal biliary obstruction., Methods: Multicenter retrospective study was conducted in patients who underwent plastic stent (PS) or nasobiliary catheter (NBC) placement for resectable malignant distal biliary obstruction followed by surgery between January 2010 and March 2012. Procedure-related adverse events, stent/catheter dysfunction (occlusion or migration of PS/NBC, development of cholangitis, or other conditions that required repeat endoscopic biliary intervention), and jaundice resolution (bilirubin level < 3.0 mg/dL) were evaluated. Cumulative incidence of jaundice resolution and dysfunction of PS/NBC were estimated using competing risk analysis. Patient characteristics and preoperative biliary drainage were also evaluated for association with the time to jaundice resolution and PS/NBC dysfunction using competing risk regression analysis., Results: In total, 419 patients were included in the study (PS, 253 and NBC, 166). Primary cancers included pancreatic cancer in 194 patients (46%), bile duct cancer in 172 (41%), gallbladder cancer in three (1%), and ampullary cancer in 50 (12%). The median serum total bilirubin was 7.8 mg/dL and 324 patients (77%) had ≥ 3.0 mg/dL. During the median time to surgery of 29 d [interquartile range (IQR), 30-39 d]. PS/NBC dysfunction rate was 35% for PS and 18% for NBC [Subdistribution hazard ratio (SHR) = 4.76; 95%CI: 2.44-10.0, P < 0.001]; the pig-tailed tip was a risk factor for PS dysfunction. Jaundice resolution was achieved in 85% of patients and did not depend on the drainage method (PS or NBC)., Conclusion: PS has insufficient patency for preoperative biliary drainage. Given the drawbacks of external drainage via NBC, an alternative method of internal drainage should be explored.

Covered self-expandable metal stents were developed to overcome tumor in-growth through the metal mesh. Stent migration is one of their malfunctions. Recently, the partially covered wallflex stent (PCWS) was developed with flared ends to prevent migration However, difficulty has been reported in its removal. We describe the removal of a PCWS embedded in mucosal hyperplasia at the uncovered proximal flared end, visualized by using SpyGlass cholangioscopy.

Gemcitabine chemotherapy has been the standard for advanced pancreatic cancer for more than a decade. New oral fluoropyrimidines such as S-1 and capecitabine are other key drugs. Gemcitabine plus erlotinib was the only combination therapy that significantly prolonged survival, although the effect was minimal. Little or no improvement in survival with recent molecular-targeted drugs might be attributed to the very high incidence of K-ras gene mutation in pancreatic cancer. Recently, the non-gemcitabine-based-regimen of FOLFIRINOX showed significantly greater overall survival compared with gemcitabine for the first time. For biliary tract cancer, gemcitabine plus cisplatin combination chemotherapy has been proved to significantly prolong survival and will become the standard therapy. Further improvement in survival is expected by the addition of cetuximab.

Endoscopic self-expandable metal stent (SEMS) placement has become a standard palliative therapy for patients with malignant biliary obstruction. Acute cholecystitis after SEMS placement is a serious complication. We report a patient with an acute cholecystitis after covered SEMS placement, who was managed successfully with endoscopic transpapillary gallbladder drainage (ETGBD) and replacement of the covered SEMS. An 85-year-old man with pancreatic cancer suffered from acute cholecystitis after covered SEMS placement. It was impossible to perform percutaneous transhepatic gallbladder drainage. After removal of the covered SEMS with a snare, a 7Fr double pigtail stent was placed between the gallbladder and duodenum, subsequently followed by another covered SEMS insertion into the common bile duct beside the gallbladder stent. The cholecystitis improved immediately after ETGBD. ETGBD with replacement of the covered SEMS thus proved to be effective for treatment of patients with acute cholecystitis after covered SEMS placement.