Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction
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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2021
CompletedFirst Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedOctober 15, 2021
July 1, 2021
1 year
August 5, 2021
October 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bilirubin serum level
Diminution of 20% of more on day 7 of the bilirubin serum level
7 days
Secondary Outcomes (5)
Complications
16 years
number of procedures
16 years
bilirubin serum level on day 30 and on day 90
90 days
median survival in months
16 years
number of unplanned hospital admissions
16 years
Study Arms (2)
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
All patients with perihilar malignant biliary obstruction treated with percutaneous drainage
Interventions
US or CT-guided percutaneous drainage
Eligibility Criteria
all adults patients hospitalized in Nancy University Hospital with perihilar biliary malignant obstruction who underwent either endoscopic or percutaneous approach for biliary drainage.
You may qualify if:
- hospitalization between january 2006 and march 2022
- perihilar obstruction
- indication of biliary drainage
You may not qualify if:
- distal biliary obstruction
- perihilar obstruction without indication of biliary drainage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nancy Hospital Center
Nancy, 54000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2021
First Posted
October 15, 2021
Study Start
July 15, 2021
Primary Completion
July 31, 2022
Study Completion
October 30, 2022
Last Updated
October 15, 2021
Record last verified: 2021-07