A RCT of Low MBO Drainage Strategies

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for draining bile in patients who have a blockage due to certain types of cancer, like pancreatic or bile duct cancer. The two methods being compared are called Endoscopic Ultrasound-guided Biliary Drainage (EUS-BD) and Endoscopic Retrograde Cholangiopancreatography Biliary Drainage (ERCP-BD). The main goal is to find out which method works better and is safer for keeping the bile flow open over time. Researchers will look at how long the drainage works, how successful the procedures are, and if there are any complications or the need for further treatments.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of cancer causing a blockage that is at least 2 cm away from the liver. They also need to have a bile duct that is wide enough for the procedure. Those with serious heart or lung issues, certain blood disorders, or who are pregnant cannot participate. If you join the study, you can expect to receive one of the two treatment methods and be monitored closely for outcomes like how well the drainage works and any side effects. This study is currently looking for participants, so if you or someone you know is interested, it might be worth discussing with a healthcare provider.

Gender

ALL

Eligibility criteria

• 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.