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NCT Number: NCT06196164

A RCT of Low MBO Drainage Strategies

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. stent patency time

    Time frame: 0-24months

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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