Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

October 1, 2021 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Nancy Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all adults patients hospitalized in Nancy University Hospital with perihilar biliary malignant obstruction who underwent either endoscopic or percutaneous approach for biliary drainage.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Endoscopic drainage
ERCP and/or EUS-guided biliary drainage
Radiologic percutaneous drainage
All patients with perihilar malignant biliary obstruction treated with percutaneous drainage
Procedure: Percutaneous transhepatic biliary drainage
US or CT-guided percutaneous drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilirubin serum level
Time Frame: 7 days
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
Time Frame: 16 years
complication-free survival
16 years
number of procedures
Time Frame: 16 years
total number of procedures, including all endoscopic and radiological interventions
16 years
bilirubin serum level on day 30 and on day 90
Time Frame: 90 days
90 days
median survival in months
Time Frame: 16 years
median survival in month in each group
16 years
number of unplanned hospital admissions
Time Frame: 16 years
total number of unplanned hospital admissions (for unplanned biliary drainage, cholangitis or other complications...)
16 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI073

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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