Jaundice, Obstructive Clinical Trial
Official title:
Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study
Verified date | July 2021 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction. Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | October 30, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - hospitalization between january 2006 and march 2022 - perihilar obstruction - indication of biliary drainage Exclusion Criteria: - distal biliary obstruction - perihilar obstruction without indication of biliary drainage |
Country | Name | City | State |
---|---|---|---|
France | Nancy Hospital Center | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bilirubin serum level | Diminution of 20% of more on day 7 of the bilirubin serum level | 7 days | |
Secondary | Complications | complication-free survival | 16 years | |
Secondary | number of procedures | total number of procedures, including all endoscopic and radiological interventions | 16 years | |
Secondary | bilirubin serum level on day 30 and on day 90 | 90 days | ||
Secondary | median survival in months | median survival in month in each group | 16 years | |
Secondary | number of unplanned hospital admissions | total number of unplanned hospital admissions (for unplanned biliary drainage, cholangitis or other complications...) | 16 years |
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