Status:
ACTIVE_NOT_RECRUITING
A RCT of Low MBO Drainage Strategies
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Jaundice, Obstructive
Cholangiopancreatography, Endoscopic Retrograde
Eligibility:
All Genders
18+ years
Phase:
NA
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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06196164
Start Date
January 25 2024
End Date
August 1 2026
Last Update
September 5 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730