Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction

ClinicalTrials.gov ID

NCT07811791

Lead Sponsor

National Taiwan University HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

70Estimated

Last Update Posted

Sep 10, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Mar 30, 2028Estimated

Completion Date

Feb 28, 2029Estimated

Official Title

Suprapapillary Versus Transpapillary Biliary Plastic Stents for Unresectable High-grade Malignant Hilar Biliary Obstruction

Brief Summary

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.

Detailed Description

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.

• Biliary Tract Neoplasms
• Biliary Drainage
• Malignant Biliary Obstruction
• Obstructive Jaundice

• Suprapapillary plastic stent placement
• Transpapillary plastic stent placement

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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
• No stent previously placed in the biliary system
• Written informed consent for participation in the study

Exclusion Criteria:

• 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

  • Previous placement of external biliary drainage (e.g., percutaneous transhepatic biliary drainage)
  • Primary sclerosing cholangitis, immunoglobulin G4-associated cholangitis, or primary biliary cholangitis
  • Pregnancy
  • Patients who opt for self-paid metal stent placement and are judged suitable for metal stents by the treating physician

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

National Taiwan University HospitalOTHER

shawnchang0524@ntuh.gov.tw+886-972653951

shawnchang0524@ntuh.gov.tw+886-972653951

sfstruck@gmail.com+886-972652398

shawnchang0524@ntuh.gov.tw+886-972653951

shawnchang0524@ntuh.gov.tw+886-972653951

• Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis

  NCT07325877

  Not yet recruitingInterventionalNot ApplicableUpdated Jan 8, 2026
• Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)

  NCT07558304

  Not yet recruitingInterventionalNot ApplicableUpdated Jun 16, 2026
• Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

  NCT06671418

  Enrolling by invitationInterventionalPhase 3Updated Nov 4, 2024
• Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

  NCT01038713

  CompletedInterventionalNot ApplicableUpdated Jun 23, 2016
• Comparison Between Transpapillary and Suprapapillary Metal Stent

  NCT04503291

  Unknown statusInterventionalNot ApplicableUpdated Jul 22, 2022
• Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

  NCT03849859

  TerminatedInterventionalNot ApplicableUpdated Apr 1, 2021