NCT06039670

Brief Summary

To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
5.8 years until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

December 11, 2017

Last Update Submit

September 13, 2023

Conditions

Biliary StrictureBiopsy WoundOncology

Outcome Measures

Primary Outcomes (3)

  • Efficacy of PTBD

    Efficacy of PTBD : bilirubinemia after PTFB at Day 7

    7 days

  • accuracy for percutaneous biliary biopsy (PTFB)

    Accuracy of PTFB : percentage of true positive and true negative results by pathologists

    from baseline up to 1 month

  • incidence of PTFB-related adverse events

    Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification

    up to 1 month after procedure

Interventions

biliary biopsyPROCEDURE

biliary biopsy through a percutaneous approach during a percutaneous biliary drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with obstructive jaundice referred for percutaneous transhepatic biliary drainage without histological diagnosis

You may qualify if:

  • Patients with biliary strictures without histology available

You may not qualify if:

  • Pregnant patients
  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Audrey Fohlen

    Caen UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

September 15, 2023

Study Start

January 2, 2015

Primary Completion

July 31, 2015

Study Completion

August 31, 2016

Last Updated

September 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share