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Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter

NCT00160836 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2007-04-19

No results posted yet for this study

Summary

Introduction In patients with a biliary obstruction, tissue is acquired immediately before drainage during endoscopic retrograde cholangio-pancreatography (ERCP). This is performed by passing a brush inside the bile duct stricture. However, brush cytology has a modest sensitivity (30-57%) for the diagnosis of cancer. A device, called the "G.I.U.M." catheter, allows for the sampling of higher amounts of tissue during ERCP compared to brush cytology. The aim of this study is to compare the diagnostic yield of tissue sampling performed in patients with a suspected malignant biliary stricture using 2 techniques, namely a standard brush catheter and the G.I.U.M..

Protocol design Eligible patients will have tissue sampling performed using both techniques during ERCP, the first technique used being randomly assigned and immediately followed by the other one as well as biliary decompression. All specimens obtained will be subjected to cytopathological examination. After inclusion of the total number of patients, smears will be anonymized and analyzed for diagnosis, cell cellularity and quality. The final clinical diagnosis in each case will be based on cytologic results plus histological examination of biopsy specimens.

Conditions

Interventions

DEVICE

Tissue sampling ("G.I.U.M." catheter)

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Jean-Marc Dumonceau, MD,PhD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31

Countries

  • Argentina

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00160836 on ClinicalTrials.gov