Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods
|ClinicalTrials.gov Identifier: NCT01227382|
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Accuracy of Tissue Diagnosis Bile Duct Stricture Pancreatic Duct Stricture||Procedure: ERCP with cholangiopancreatoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Accuracy of Spybite Biopsy Forceps for the Tissue Diagnosis of Lesion of the Pancreatobiliary System. ( Part of the "The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Treatment of Pancreaticobiliary Disorders" Study)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
ERCP with Cholangiopancreatoscopy
The subjects who have been scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangiopancreatoscopy for evaluation of a bile duct or pancreatic duct stricture sampling.
Procedure: ERCP with cholangiopancreatoscopy
Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps
- Percentage of Participants With Accurate Diagnoses of Cancer [ Time Frame: up to 7 days after the procedure ]The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.
- Procedure Technical Success [ Time Frame: day 1 ]The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.
- Total Procedure Time [ Time Frame: 120 minutes ]The total time to perform ERCP
- Total Cholangioscopy Time [ Time Frame: 60 minutes ]This is the total time it takes for the dye to be performed during the ERCP.
- Cholangioscopy Visualization Time [ Time Frame: 30 minutes ]The portion of the total ERCP time spent on Cholangioscopy visualization.
- Sampling Times for Each Device [ Time Frame: 15 minutes ]The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).
- Adverse Events [ Time Frame: 24 hours ]Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227382
|United States, Florida|
|Shands at UF Ensopcopy|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Peter Draganov, MD||University of Flordia|