An interventional study of Suprapapillary plastic stent placement and Transpapillary plastic stent placement in Biliary Tract Neoplasms, Biliary Drainage and Malignant Biliary Obstruction, sponsored by National Taiwan University Hospital. Not yet recruiting at 8 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.
This study's planned enrollment of 70 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Previous endoscopic or surgical ampullectomy, papilloplasty, or surgical bilioenteric anastomosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endoscopic placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent), with the distal end positioned within the bile duct and the sphincter of Oddi preserved, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction.
Procedure: Suprapapillary plastic stent placement
Endoscopic placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction.
Procedure: Transpapillary plastic stent placement
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
Also known as: 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 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.
Time frame: From stent placement until RBO, death, or end of follow-up, assessed up to 12 months
Overall survival
Time from stent placement to death from any cause. Participants alive at last follow-up are censored.
Time frame: From stent placement until death or end of follow-up, assessed up to 12 months
Technical success rate
Proportion of participants with successful stent placement across or above the stricture in the intended position, confirmed by cholangiography.
Time frame: During the index ERCP procedure (Day 0)
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.
Time frame: Within 14 days after stent placement
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.
Time frame: ：From stent placement until end of follow-up, assessed up to 12 months
Plan to share: No — Individual participant data will not be shared, in accordance with the informed consent obtained and institutional data protection regulations. Data are stored on the institutional REDCap server of National Taiwan University Hospital and are not permitted to be transferred outside the hospital network. Aggregate results will be published in peer-reviewed journal.
Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.
Of 25 interventional studies with no phase under Biliary Tract Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 63. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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