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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05078801
Other study ID # 2021PI073
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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