NCT06196164

A RCT of Low MBO Drainage Strategies

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Jaundice, Obstructive
• Cholangiopancreatography, Endoscopic Retrograde
• Endoscopic Ultrasound-Guided Drainage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-25
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-01-09
• Last updated: 2025-09-05

Locations

1 site across 1 country: China