Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Perihilar Cholangiocarcinoma, Jaundice, Obstructive

Intervention / Treatment
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* Procedure: Endoscopic drainage
* Procedure: Percutaneous transhepatic biliary drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic drainage<br>All patients with perihilar malignant biliary obstruction treated with endoscopic drainage. This drainage can be multimodal using endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)-guided biliary drainage. | Procedure: Endoscopic drainage<br>* ERCP and/or EUS-guided biliary drainage<br>|
| Radiologic percutaneous drainage<br>All patients with perihilar malignant biliary obstruction treated with percutaneous drainage | Procedure: Percutaneous transhepatic biliary drainage<br>* US or CT-guided percutaneous drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubin serum level | Diminution of 20% of more on day 7 of the bilirubin serum level | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | complication-free survival | 16 years | 
| number of procedures | total number of procedures, including all endoscopic and radiological interventions | 16 years | 
| bilirubin serum level on day 30 and on day 90 |  | 90 days | 
| median survival in months | median survival in month in each group | 16 years | 
| number of unplanned hospital admissions | total number of unplanned hospital admissions (for unplanned biliary drainage, cholangitis or other complications...) | 16 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, EUS-guided biliary drainage, Percutaneous transhepatic biliary drainage, hilar obstruction