Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial.

(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study.

Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial.

BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones.

A randomized-controlled trial of early endotherapy versus wait-and-see policy for mild symptomatic pancreatic stones in chronic pancreatitis.

Background: Although surgical or endoscopic treatment is effective for pain control in symptomatic calcified chronic pancreatitis, it is still unknown whether early intervention in mild symptomatic pancreatic stones would reduce the frequency of acute exacerbation and improve long-term outcomes. The aim of this randomized-controlled trial was to explore the efficacy of early endotherapy for mild symptomatic pancreatic stones in comparison with the wait-and-see policy.

Materials And Methods: Patients with mild symptoms because of pancreatic stones were assigned randomly to the endotherapy or the wait-and-see group.

Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial.

Background And Aim: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self-expandable metal stents (SEMS) has not been fully examined.

Methods: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel-shaped valve was longer than that of a covered SEMS in SEMS-naïve patients.

Early pancreatic stent placement in wire-guided biliary cannulation: A multicenter retrospective study.

Background And Aim: Guidewire insertion to a pancreatic duct under wire-guided cannulation (WGC) during endoscopic retrograde cholangiopancreatography (ERCP) is associated with a high incidence of post-ERCP pancreatitis (PEP). Pancreatic stent placement followed by WGC (PS-WGC) is considered for these cases to reduce PEP. This study was aimed to examine the effectiveness of PS-WGC compared with repeated WGC.

A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer.

Objective: Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients.

Methods: Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups.

Preoperative biliary drainage using a fully covered self-expandable metallic stent for pancreatic head cancer: A prospective feasibility study.

Background/aims: The role of endoscopic preoperative biliary drainage (PBD) for pancreatic head cancer is controversial because of the high incidence of stent occlusion before surgery. This study was performed to evaluate the feasibility and safety of PBD using a fully covered self-expandable metallic stent (FCSEMS).

Patients And Methods: This multicenter prospective study involved 26 patients treated for pancreatic head cancer with distal bile duct obstruction from April 2011 to March 2013.

A 19-Gauge Histology Needle Versus a 19-Gauge Standard Needle in Endoscopic Ultrasound-Guided Fine-Needle Aspiration for Solid Lesions: A Multicenter Randomized Comparison Study (GREATER Study).

Background: The necessity of histological analysis is increasing. A 19-gauge histology needle (PC19) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has recently been developed and has shown high yields of tissue acquisition and histological diagnosis.

Aims: To compare the histological diagnostic yield in single-pass EUS-FNA for solid lesions using PC19 and a standard 19-gauge needle (EC19).

Multicenter retrospective and comparative study of 5-minute versus 15-second endoscopic papillary balloon dilation for removal of bile duct stones.

Background And Study Aims:  Endoscopic papillary balloon dilation (EPBD) is a method of bile duct stone removal that has a better long-term outcome but a high risk of post-ERCP pancreatitis (PEP). Recent studies have suggested that 5-minute EPBD can reduce the incidence of PEP. This study aimed to examine the safety and effectiveness of longer duration EPBD compared with shorter duration EPBD (5 minutes vs.

International study of endoscopic management of distal malignant biliary obstruction combined with duodenal obstruction.

Objective: Endoscopic transpapillary or endoscopic ultrasound (EUS)-guided stent placement is used for nonresectable distal malignant biliary obstruction. We conducted a retrospective study to evaluate endoscopic biliary drainage in patients with duodenal obstruction.

Methods: We included consecutive patients who underwent endoscopic biliary drainage combined with a duodenal stent at 16 referral centers in four Asian countries.

A Novel Partially Covered Self-Expandable Metallic Stent with Proximal Flare in Patients with Malignant Gastric Outlet Obstruction.

Background/aims: Endoscopic placement of self-expandable metal stents (SEMSs) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although covered SEMSs can prevent tumor ingrowth, frequent migration of covered SEMSs may offset their advantages in preventing tumor ingrowth.

Methods: We conducted this multicenter, single-arm, retrospective study at six tertiary referral centers to evaluate the safety and efficacy of a partially covered SEMS with an uncovered large-bore flare at the proximal end as an antimigration system in 41 patients with symptomatic malignant GOO.

Gemcitabine and S-1 versus gemcitabine and cisplatin treatment in patients with advanced biliary tract cancer: a multicenter retrospective study.

Objective This study aimed to compare the safety and efficacy of the combination therapy of gemcitabine and S-1 (GS) versus gemcitabine and cisplatin (GC) in patients with advanced biliary tract cancer (BTC). Methods In this multicenter retrospective cohort study, a total of 212 patients with advanced BTC receiving GS (n = 125) or GC (n = 87) between July 2006 and August 2015 were analyzed. The primary endpoint was overall survival (OS).

Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study.

Background/aims: In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent.

Methods: Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers.

Multicenter study of endoscopic preoperative biliary drainage for malignant distal biliary obstruction.

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.

Antireflux metal stent with an antimigration system for distal malignant biliary obstruction: a feasibility pilot study.

An antireflux metal stent (ARMS) for distal malignant biliary obstruction has been reported to be useful, but the effectiveness of a flared-end structure to prevent migration on ARMS remains unclear. To evaluate the feasibility of a newly designed ARMS with both ends flared, 8 patients with covered metal stent occlusion due to sludge or food impaction were enrolled. ARMS were placed successfully after endoscopic removal of the occluded stents in all patients, and no procedure-related complication was observed.

Early use of double-guidewire technique to facilitate selective bile duct cannulation: the multicenter randomized controlled EDUCATION trial.

Background And Study Aims: There are no guidelines for the timing of conversion from a single-guidewire to a double-guidewire technique to facilitate selective bile duct cannulation and reduce post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), when using wire-guided 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 wire-guided cannulation in whom there was unintentional insertion of the guidewire into the pancreatic duct.

Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction.

Background And Aim: To evaluate the efficacy and safety of secondary gastroduodenal stent placement after first stent dysfunction for malignant gastric outlet obstruction.

Methods: We conducted a retrospective analysis to investigate the efficacy and safety of secondary stent-in-stent gastroduodenal stent placement.

Results: Among 260 patients who had been treated with first gastroduodenal stent placement for malignant gastric outlet obstruction, 29 patients (11.

Transmural biliary drainage can be an alternative to transpapillary drainage in patients with an indwelling duodenal stent.

Background: Self-expandable metal stents (SEMS) are widely utilized to relieve symptoms of malignant gastric outlet obstruction (GOO), but GOO is frequently complicated by nonresectable distal biliary obstruction. The optimal endoscopic approach to biliary drainage in this setting remains controversial and has yet to be resolved.

Aims: To compare the safety and efficacy of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) and transpapillary drainage in patients with an indwelling duodenal SEMS.

Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer.

Background And Aim: Covered metallic stents (CMSs) were developed to overcome tumor ingrowth in uncovered metallic stents (UMSs) for malignant biliary obstruction, but superiority of CMSs over UMSs is still controversial due to the high migration rate in CMS. Therefore, we conducted this retrospective analysis to clarify risk factors for stent migration, including mechanical properties of CMSs.

Methods: Patients with unresectable pancreatic cancer, receiving CMS for distal malignant biliary obstruction in five tertiary care centers, were retrospectively studied.

Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction.

Background And Aim: Tumor involvement to the orifice of cystic duct (OCD) is a risk factor for cholecystitis after self-expandable metallic stent (SEMS) placement, but its prevention is still difficult. We conducted this multicenter analysis to clarify a type of SEMS or a method to place SEMS which would decrease the incidence of cholecystitis after SEMS placement.

Methods: The incidence of cholecystitis was studied in consecutive patients receiving SEMS for distal malignant biliary obstruction in five tertiary care centers.

Results of the Tokyo trial of prevention of post-ERCP pancreatitis with risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial.

Background: Our previous study suggested that a combination of ulinastatin and risperidone reduced post-ERCP pancreatitis (PEP) compared with ulinastatin alone.

Objective: The aim of this study was to evaluate the efficacy of risperidone alone for prevention of PEP.

Design: A multicenter, randomized, placebo-controlled, double-blind clinical trial.

Estimation and comparison of cumulative incidences of biliary self-expandable metallic stent dysfunction accounting for competing risks.

Background: Self-expandable metallic stent (SEMS) placement is widely carried out for distal malignant biliary obstruction, and survival analysis is used to evaluate the cumulative incidences of SEMS dysfunction (e.g. the Kaplan-Meier [KM] method and the log-rank test).

Novel antireflux covered metal stent for recurrent occlusion of biliary metal stents: a pilot study.

Background: Feasibility of antireflux metal stent (ARMS), designed to prevent duodenobiliary reflux, was reported in patients with distal malignant biliary obstruction. In this prospective pilot study, we aimed to evaluate a newly designed ARMS as a reintervention for self-expandable metallic stent (SEMS) occlusion believed to be caused by duodenobiliary reflux.

Patients And Methods: Patients with non-resectable distal malignant biliary obstruction were included in whom a prior SEMS was occluded as a result of sludge or food impaction between March 2010 and January 2012 at two Japanese tertiary referral centers.

Management of dysfunctional covered self-expandable metallic stents in patients with malignant distal biliary obstruction.

Background: Endoscopic placement of covered self-expandable metallic stents (CSEMSs) is effective for distal malignant biliary obstruction. However, management of dysfunctional CSEMSs has not been established.

Methods: Between March 1998 and July 2007, a total of 74 patients who underwent endoscopic re-interventions for CSEMS dysfunction were analyzed.