Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05078801
• Other study ID #: 2021PI073
• Status: Active, not recruiting
• Start date: July 15, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: July 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Jaundice
• Jaundice, Obstructive
• Klatskin Tumor
• Perihilar Cholangiocarcinoma

Intervention

Procedure:
• Endoscopic drainage
ERCP and/or EUS-guided biliary drainage
• Percutaneous transhepatic biliary drainage
US or CT-guided percutaneous drainage

Locations

Country	Name	City	State
France	Nancy Hospital Center	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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