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CompletedNCT06039670Updated Sep 15, 2023

Percutaneous Transluminal Forceps Biopsy

An observational study in Biliary Stricture, Biopsy Wound and Oncology, sponsored by University Hospital, Caen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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

Read the detailed description

Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy

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Conditions studied

  • Biliary Stricture
  • Biopsy Wound
  • Oncology

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03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 50 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.

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Lead sponsor

University Hospital, Caen is the lead sponsor of 510 studies on the registry; 80 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

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

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

  • Patients with biliary strictures without histology available

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients
  • Children
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Target follow-up
7 Months
Patient registry
Yes

Interventions

  • Procedurebiliary biopsy

    biliary biopsy through a percutaneous approach during a percutaneous biliary drainage

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What researchers measure

Primary outcomes

  1. Efficacy of PTBD

    Efficacy of PTBD : bilirubinemia after PTFB at Day 7

    Time frame: 7 days

  2. accuracy for percutaneous biliary biopsy (PTFB)

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

    Time frame: from baseline up to 1 month

  3. 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

    Time frame: up to 1 month after procedure

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06039670
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Jan 2, 2015
Primary completion
Jul 31, 2015
Completion
Aug 31, 2016
Last update
Sep 15, 2023

Study contacts

Audrey Fohlen
principal investigator · Caen UH

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 completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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