A RCT of Low MBO Drainage Strategies

NCT06196164 | Active Not Recruiting

• 1 other identifier: K3807
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• stent patency time

  The interval between the operation day and the occurrence of cholangitis and biliary obstruction

  0-24months

Study Arms (2)

EUS-BD

EXPERIMENTAL

Endoscopic Ultrasound-guided Biliary Drainage

Procedure: EUS-BD

ERCP-BD

OTHER

Endoscopic Retrograde Cholangiopancreatography

Procedure: ERCP-BD

Interventions

EUS-BD PROCEDURE

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.

EUS-BD

ERCP-BD PROCEDURE

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.

ERCP-BD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
• Uncorrectable coagulation abnormalities or bleeding tendencies (INR\>1.5 or platelets\<50) × 109 /L);
• 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;
• Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
• Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
• Pregnancy, lactation, or planned pregnancy;
• Refusal to join or inability to provide informed consent;
• Other researchers evaluated the unsuitability of enrollment.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Xi WU

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor，M.D.

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 9, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

CN (1)