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A RCT of Low MBO Drainage Strategies

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

NCT06196164•Peking Union Medical College Hospital

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age:18 years old or above;
•2. Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;
•3. Distal malignant bile duct obstruction (2cm away from the hepatic hilum);
•4. Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;
•5. The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.

Exclusion Criteria

•1. Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
•2. Uncorrectable coagulation abnormalities or bleeding tendencies (INR\>1.5 or platelets\<50) × 109 /L);
•3. There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months;
•4. Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
•5. Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
•6. Pregnancy, lactation, or planned pregnancy;
•7. Refusal to join or inability to provide informed consent;
•8. Other researchers evaluated the unsuitability of enrollment.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

January 25, 2024

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

September 5, 2025

Enrollment

ACTUAL participants

Conditions

Jaundice, ObstructiveCholangiopancreatography, Endoscopic RetrogradeEndoscopic Ultrasound-Guided Drainage

Interventions

EUS-BD

PROCEDURE

ERCP-BD

PROCEDURE

Antimicrobial Resistance in Acute Cholangitis

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Cholangitis AcuteBiliary Tract Diseases+3 more

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ENROLLING_BY_INVITATION

Prospective Evaluation of Biliary Tissue Sampling with ERCP

NCT04572711

Cholangiopancreatography, Endoscopic RetrogradeBiliary Stricture+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A RCT of Low MBO Drainage Strategies

Inclusion Criteria

Exclusion Criteria

Antimicrobial Resistance in Acute Cholangitis

Prospective Evaluation of Biliary Tissue Sampling with ERCP

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries

A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?

Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation