NCT Number: NCT07811791
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results.
This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
National Taiwan University Hospital Hsinchu Branch, Biomedical Park Hospital, Hsinchu, Taiwan
Malignant hilar biliary obstruction (MHBO) is among the most challenging conditions in therapeutic biliary endoscopy. Uncovered self-expandable metal stents provide longer patency but cannot be removed, which complicates reintervention as oncologic therapy prolongs survival. Plastic stents remain a removable, reversible option, though with shorter patency. The suprapapillary (inside) plastic stent concept, proposed in 1998, aims to prolong stent patency and reduce ascending bacterial infection by preserving the sphincter of Oddi, but existing evidence is limited to small trials and retrospective series with inconsistent results, and no adequately powered randomized trial has addressed high-grade hilar obstruction.
This is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial conducted at eight institutions in Taiwan. Patients with unresectable Bismuth type II or higher MHBO are randomized 1:1 to suprapapillary or transpapillary plastic stent placement. Randomization is performed after successful biliary cannulation during ERCP, using a centralized web-based system (REDCap) with stratification by site. The primary endpoint is time to recurrent biliary obstruction (TRBO). Secondary endpoints include overall survival, technical and clinical success, reintervention rate, and adverse events. Participants are followed until recurrent biliary obstruction, death, or the end of the study period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent). The distal end of the stent remains within the
Other names: iPS
Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen. Commercially available, regulatory-approved plastic biliary stents are used; stent size and number are determined by the endoscopist according to the stricture anatomy.
Time frame: From stent placement until RBO, death, or end of follow-up, assessed up to 12 months
Time from stent placement to recurrent biliary obstruction (RBO), defined as stent occlusion or symptomatic stent migration requiring biliary reintervention. Participants without RBO are censored at death, elective stent removal or exchange, or last follow-up. Estimated by the Kaplan-Meier method.
Time frame: From stent placement until death or end of follow-up, assessed up to 12 months
Time from stent placement to death from any cause. Participants alive at last follow-up are censored.
Time frame: During the index ERCP procedure (Day 0)
Proportion of participants with successful stent placement across or above the stricture in the intended position, confirmed by cholangiography.
Time frame: Within 14 days after stent placement
Proportion of participants with adequate biliary drainage after stent placement, defined as a decrease in serum total bilirubin to less than 50% of the pre-procedure value or below a prespecified threshold.
Time frame: ：From stent placement until end of follow-up, assessed up to 12 months
Adverse events including post-ERCP pancreatitis, cholangitis, cholecystitis, bleeding, perforation, and stent migration, graded according to the ASGE lexicon severity grading system.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Suprapapillary Versus Transpapillary Biliary Plastic Stents for Unresectable High-grade Malignant Hilar Biliary Obstruction
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