EUS-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.
ERCP-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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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:
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.
Primary outcome measure(s)
stent patency time — 0-24months The interval between the operation day and the occurrence of cholangitis and biliary obstruction
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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