Malignant Biliary Obstruction
Conditions
Brief summary
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: * Prospective randomized controlled study * Patients were randomly divided into two groups, EUS-BD group or ERCP group * Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary drainage)for decompression of malignant biliary obstruction * After the procedure, regular follow up, blood test, and imaging test will be done to check sufficient biliary decompression, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events rate. 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.
Detailed description
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.
Interventions
PROCEDUREERCP assisted trans-papillary drainage for malignant biliary obstruction
ERCP assisted trans-papillary drainage for malignant biliary obstruction
PROCEDUREEUS-guide biliary drainage for malignant biliary obstruction
EUS-guide biliary drainage for malignant biliary obstruction
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age: 18 - 85 years * a patients who had malignant biliary obstruction confirmed by imaging examinations and Pathological examination * Hyperbilirubinemia (total bilirubin \>= 1.5 mg/dl) * inoperable state * patients who agree to join this study
Exclusion criteria
* a patients who cannot endure sedation or therapeutic endoscopic procedure * a patients with bleeding tendency (PT \> 1.5 INR, PLT \< 50,000) * patients underwent biliary drainage by surgery, ERCP or percutaneous transhepatic biliary drainage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rates | one month after the procedures. | The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures. |
| Adverse events rates | within 6-9 months after the procedures | The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-intervention rates | within 6-9 months from the procedures | Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion) |
| Evaluation of the cost of the procedure and hospitalization. | Up to 30 days after the intervention. | Evaluation of the cost for different procedures. |
| overall survival | within 6-9 months from the procedures | death in the follow up after endoscopic treatment |
Countries
China
Outcome results
None listed