An interventional study of ERCP assisted trans-papillary drainage for malignant biliary obstruction and EUS-guide biliary drainage for malignant biliary obstruction in Malignant Biliary Obstruction, sponsored by First People's Hospital of Hangzhou. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction.
Subjects of the study: Patients who have malignant biliary obstruction.
Methods of the study:
Statistical methods: SPSS 23.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.
ERCP is a well-established procedure for the management of malignant biliary obstruction. However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive options are usually considered, which including percutaneous trans-hepatic biliary drainage and surgical intervention, but they all have been associated with a higher risk of complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent, particularly a lumen-apposing metal stent, is a promising technique for biliary decompression in patients with failed ERCP. There has been growing global experience with EUS-BD in recent years, and data from expert centers support the feasibility and efficacy of EUS-BD. However, few researches compared the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction. The investigators herein aim to conduct a randomized controlled clinical trial to compare the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction.
First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ERCP assisted trans-papillary drainage for malignant biliary obstruction
Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction
EUS-guide biliary drainage for malignant biliary obstruction
Procedure: EUS-guide biliary drainage for malignant biliary obstruction
ERCP assisted trans-papillary drainage for malignant biliary obstruction
EUS-guide biliary drainage for malignant biliary obstruction
Clinical success rates
The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.
Time frame: one month after the procedures.
Adverse events rates
The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.
Time frame: within 6-9 months after the procedures
Re-intervention rates
Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion)
Time frame: within 6-9 months from the procedures
Evaluation of the cost of the procedure and hospitalization.
Evaluation of the cost for different procedures.
Time frame: Up to 30 days after the intervention.
overall survival
death in the follow up after endoscopic treatment
Time frame: within 6-9 months from the procedures
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou