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.
Age 18 years or older
Unresectable high-grade malignant hilar biliary obstruction (Bismuth type II, III, or IV) diagnosed by CT, MRI, and/or previous surgical specimen
Need for biliary drainage due to biliary obstruction (serum total bilirubin ≥2 mg/dL or diagnosis of cholangitis)
Life expectancy greater than 3 months
Condition not allowing endoscopic intervention
Failed biliary cannulation
Surgically altered anatomy of the upper gastrointestinal tract, excluding Billroth-I reconstruction
Previous endoscopic or surgical ampullectomy, papilloplasty, or surgical bilioenteric anastomosis
Parallel
Suprapapillary plastic stent placement
Procedure/SurgeryEndoscopic 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
Transpapillary plastic stent placement
Procedure/SurgeryEndoscopic 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 to recurrent biliary obstruction (TRBO)
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.
Overall survival
Time from stent placement to death from any cause. Participants alive at last follow-up are censored.
Technical success rate
Proportion of participants with successful stent placement across or above the stricture in the intended position, confirmed by cholangiography.
Clinical success rate
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.
Incidence of procedure- and stent-related adverse events
Adverse events including post-ERCP pancreatitis, cholangitis, cholecystitis, bleeding, perforation, and stent migration, graded according to the ASGE lexicon severity grading system.
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