Ignite Creation Date:
2024-05-06 @ 1:56 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01935180
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2012-01-19
Brief Title:
Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps CAP Trial
Sponsor:
White River Junction Veterans Affairs Medical Center
Organization:
White River Junction Veterans Affairs Medical Center
Study Overview
Official Title:
Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps CAP Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP
Brief Summary:
Effectiveness of screening colonoscopy in cancer prevention relies on the detection and removal of adenomatous polyps However a substantial rate of adenomas is missed during a colonoscopy It has been estimated that two thirds of missed adenomas are located on the proximal aspect of colonic folds Attaching a transparent cap to the tip of a colonoscope may allow examination of the proximal aspect of colonic folds and some early studies have suggested an increased polyp and adenoma detection using this technology However the studies have in part substantial methodological limitations eg missing polyp histology single endoscopist study polyps not removed at the time of detection Therefore at this point it is unclear whether cap assisted colonoscopy may improve adenoma detection The objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma detection
The investigators propose a two-center multiple endoscopists randomized controlled trial Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy Primary outcome measure is the adenoma detection rate mean number of adenoma per patient The investigators will assess and adjust for possible variables that can affect adenoma detection including withdrawal time and quality of colon preparation As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists a minimum of six new to this method In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology
The investigators propose a two-center multiple endoscopists randomized controlled trial Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy Primary outcome measure is the adenoma detection rate mean number of adenoma per patient The investigators will assess and adjust for possible variables that can affect adenoma detection including withdrawal time and quality of colon preparation As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists a minimum of six new to this method In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology
Detailed Description:
All patients who present for a colonoscopy and meet inclusion and exclusion criteria will be asked to participate see inclusion and exclusion criteria All patients will undergo a regular bowel preparation with polyethylene glycol lavage based on current standard of care until clear rectal fluid is evacuated Patients will be randomized to one of two groups
1 Standard colonoscopy or
2 Cap assisted colonoscopy All colonoscopies will be performed using state of the art high-definition wide angle colonoscopy The transparent cap which is attached to the tip of the colonoscope has a 4mm margin extending beyond the tip of the colonoscope All patients will undergo a careful endoscopic examination A timer will provide feedback on the time of insertion and the withdrawal time Detected polyps will be assessed with standard white light and narrow band imaging to predict polyp histology adenoma versus no adenoma then resected and sent for histological evaluation according to standard of care At least 8 experienced endoscopists at the participating centers will participate Each endoscopist will perform at least 50 cap assisted colonoscopies as part of the study Each endoscopist will be asked to complete a survey after 10 and after 50 cap assisted colonoscopies
Patients will be randomized in blocks of four allocated to each examiner The order of randomization will be computer generated Information on randomization will be contained in sealed envelopes assigned to each examiner and individually opened immediately before the procedure after a patients All participating endoscopist will fill out a questionnaire regarding the use of cap assistance colonoscopy after the initial 10 cap assisted colonoscopies and after at least 50 cap assisted cap colonoscopies Endoscopists will also undergo a training session with respect to real time polyp diagnosis before study commencement and after each 20 colonoscopies enrollment
1 Standard colonoscopy or
2 Cap assisted colonoscopy All colonoscopies will be performed using state of the art high-definition wide angle colonoscopy The transparent cap which is attached to the tip of the colonoscope has a 4mm margin extending beyond the tip of the colonoscope All patients will undergo a careful endoscopic examination A timer will provide feedback on the time of insertion and the withdrawal time Detected polyps will be assessed with standard white light and narrow band imaging to predict polyp histology adenoma versus no adenoma then resected and sent for histological evaluation according to standard of care At least 8 experienced endoscopists at the participating centers will participate Each endoscopist will perform at least 50 cap assisted colonoscopies as part of the study Each endoscopist will be asked to complete a survey after 10 and after 50 cap assisted colonoscopies
Patients will be randomized in blocks of four allocated to each examiner The order of randomization will be computer generated Information on randomization will be contained in sealed envelopes assigned to each examiner and individually opened immediately before the procedure after a patients All participating endoscopist will fill out a questionnaire regarding the use of cap assistance colonoscopy after the initial 10 cap assisted colonoscopies and after at least 50 cap assisted cap colonoscopies Endoscopists will also undergo a training session with respect to real time polyp diagnosis before study commencement and after each 20 colonoscopies enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None