Biliary Drainage, Biliary Tract Neoplasms, Malignant Biliary Obstruction, Obstructive Jaundice
Conditions
Keywords
suprapapillary stent, inside stent, transpapillary stent, plastic biliary stent, ERCP, endoscopic biliary drainage, stent patency, time to recurrent biliary obstruction, Bismuth classification
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.
Interventions
PROCEDURESuprapapillary 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
PROCEDURETranspapillary plastic stent placement
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized 1:1 to suprapapillary or transpapillary plastic stent placement after successful biliary cannulation during ERCP.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrent biliary obstruction (TRBO) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
| Technical success rate | 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. |
| Clinical success rate | 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. |
| Incidence of procedure- and stent-related adverse events | ：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. |
Countries
Taiwan
Contacts
CONTACTSheng Jie Chang, Medical doctor
PRINCIPAL_INVESTIGATORYu-Ting Kuo, Medical doctor
National Taiwan University Hospital
Outcome results
None listed