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Active, not recruitingNCT06196164Updated Sep 5, 2025

A RCT of Low MBO Drainage Strategies

An interventional study of EUS-BD and ERCP-BD in Jaundice, Obstructive, Cholangiopancreatography, Endoscopic Retrograde and Endoscopic Ultrasound-Guided Drainage, sponsored by Peking Union Medical College Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

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

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    EUS-BD

    Endoscopic Ultrasound-guided Biliary Drainage

    Procedure: EUS-BD

  • Other
    ERCP-BD

    Endoscopic Retrograde Cholangiopancreatography

    Procedure: ERCP-BD

Interventions

  • ProcedureEUS-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.

  • ProcedureERCP-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.

05

What researchers measure

Primary outcomes

  1. stent patency time

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

    Time frame: 0-24months

06

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
07

Registry details

Key details

Study ID
NCT06196164
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Wu Xi (associate professor,M.D., Peking Union Medical College Hospital) — Principal investigator
First posted
Jan 9, 2024
Start date
Jan 25, 2024
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Sep 5, 2025

Study contacts

Xi WU
study director · Peking Union Medical College Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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