Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter
1 other identifier
interventional
68
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedApril 19, 2007
April 1, 2007
September 8, 2005
April 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity for the diagnosis of malignancy with both devices
Secondary Outcomes (2)
30-day complication rate.
unusual findings at histopathological examination of surgical specimens.
Interventions
Eligibility Criteria
You may qualify if:
- Suspicion of malignant biliary stricture without prior histopathologic confirmation;
- Informed consent for ERCP, including sampling and dilation modalities, obtained.
You may not qualify if:
- Coagulopathy not corrected by administration of vitamin K or fresh frozen plasma;
- Inability to pass a guidewire through the stricture;
- Hilar stricture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Servicio de GastroenterologĂa, Hospital Italiano
Buenos Aires, 1428, Argentina
Clinica SUIZO-ARGENTINA
Buenos Aires, 1461, Argentina
Department of Gastroenterology, San Martin Hospital
La Plata, 1900, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean-Marc Dumonceau, MD,PhD
University Hospital, Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
October 1, 2004
Last Updated
April 19, 2007
Record last verified: 2007-04