MedTrace Logo

A RCT of Low MBO Drainage Strategies

NCT06196164 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Xi WU · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-25
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06196164 on ClinicalTrials.gov