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Trial Title:
A RCT of Low MBO Drainage Strategies
NCT ID:
NCT06196164
Condition:
Jaundice, Obstructive
Cholangiopancreatography, Endoscopic Retrograde
Endoscopic Ultrasound-Guided Drainage
Conditions: Official terms:
Jaundice
Jaundice, Obstructive
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
EUS-BD
Description:
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.
Arm group label:
EUS-BD
Intervention type:
Procedure
Intervention name:
ERCP-BD
Description:
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.
Arm group label:
ERCP-BD
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Xi Wu, M.D.
Phone:
+8613683296860
Email:
wxpumch@163.com
Start date:
January 25, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196164
