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Status unknownNCT05078801Updated Oct 15, 2021

Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

An observational study in Perihilar Cholangiocarcinoma and Jaundice, Obstructive, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Perihilar Cholangiocarcinoma
  • Jaundice, Obstructive

Keywords

  • ERCP
  • EUS-guided biliary drainage
  • Percutaneous transhepatic biliary drainage
  • hilar obstruction
03

In context

Klatskin Tumor

82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 23 observational studies indexed under Klatskin Tumor.

Browse Klatskin Tumor studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hospitalization between january 2006 and march 2022
  • perihilar obstruction
  • indication of biliary drainage

Exclusion criteria

Exclusion Criteria:

  • distal biliary obstruction
  • perihilar obstruction without indication of biliary drainage
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Radiologic percutaneous drainage

    All patients with perihilar malignant biliary obstruction treated with percutaneous drainage

    Procedure: Percutaneous transhepatic biliary drainage

Interventions

  • ProcedureEndoscopic drainage

    ERCP and/or EUS-guided biliary drainage

  • ProcedurePercutaneous transhepatic biliary drainage

    US or CT-guided percutaneous drainage

06

What researchers measure

Primary outcomes

  1. Bilirubin serum level

    Diminution of 20% of more on day 7 of the bilirubin serum level

    Time frame: 7 days

Secondary outcomes

  1. Complications

    complication-free survival

    Time frame: 16 years

  2. number of procedures

    total number of procedures, including all endoscopic and radiological interventions

    Time frame: 16 years

  3. bilirubin serum level on day 30 and on day 90

    Time frame: 90 days

  4. median survival in months

    median survival in month in each group

    Time frame: 16 years

  5. number of unplanned hospital admissions

    total number of unplanned hospital admissions (for unplanned biliary drainage, cholangitis or other complications...)

    Time frame: 16 years

07

Study locations

1 site
  • Nancy Hospital Center
    Nancy, 54000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05078801
Responsible party
Sponsor
First posted
Oct 15, 2021
Start date
Jul 15, 2021
Primary completion
Jul 31, 2022 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Oct 15, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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