Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

• Conditions: Perihilar Cholangiocarcinoma; Jaundice, Obstructive
• Interventions: Procedure: Endoscopic drainage; Procedure: Percutaneous transhepatic biliary drainage

• Registration Number: NCT05078801
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-15
• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-07-31
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic drainage	Endoscopic drainage	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.
Radiologic percutaneous drainage	Percutaneous transhepatic biliary drainage	All patients with perihilar malignant biliary obstruction treated with percutaneous drainage

Primary Outcome Measures

Name	Time	Method
Bilirubin serum level	7 days	Diminution of 20% of more on day 7 of the bilirubin serum level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nancy Hospital Center; 🇫🇷 Nancy, France