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ACTIVE NOT RECRUITING
NCT06196164
NA

A RCT of Low MBO Drainage Strategies

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.

Official title: A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-01-25

Completion Date

2026-08

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

PROCEDURE

EUS-BD

We observe the bile duct through endoscopic ultrasound, then puncture through the gastric or duodenum wall and place a guide wire, expanding along the guide wire, finally place a stent between the bile duct and the stomach or intestine for drainage.

PROCEDURE

ERCP-BD

We use a Duodenoscopy to pass through mouth down to the small opening where the bile duct and pancreatic drain. A small narrow catheter is passed through the scope to gain access to the drainage duct , followed by advancement of a wire deep into the duct. A small cut is made at the bile duct opening to help facilitate a stent placed in the bile duct.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China