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| Name | Class |
|---|---|
| Dartmouth-Hitchcock Medical Center | OTHER |
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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 (e.g. 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.
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:
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 patient's 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard colonoscopy | No Intervention | ||
| Cap assisted colonoscopy | Active Comparator | A transparent cap will be affixed to tip of the high-definition wide angle colonoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy Cap | Device | 4mm transparent cap (Olympus) mounted to the tip of a colonoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Adenomas | Mean number of adenomas per patient in each group. | duration of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate | • Adenoma detection rate (ADR), % of patients with at least 1 adenoma | duration of colonoscopy |
| Advanced Adenoma Detection Rate | Proportion of patients with advanced adenomas |
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Inclusion Criteria:
• Any patient ≥ 50 years old and < 85 years old who presents for a colonoscopy with a potential for polyp resection and who does not meet any of the exclusion criteria mentioned below will be asked to participate
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heiko Pohl | White River Junction VAMC, Dartmouth Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States | ||
| White River Junction VAMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29174789 | Derived | von Renteln D, Kaltenbach T, Rastogi A, Anderson JC, Rosch T, Soetikno R, Pohl H. Simplifying Resect and Discard Strategies for Real-Time Assessment of Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2018 May;16(5):706-714. doi: 10.1016/j.cgh.2017.11.036. Epub 2017 Nov 23. | |
| 27590962 | Derived | von Renteln D, Robertson DJ, Bensen S, Pohl H. Prolonged cecal insertion time is associated with decreased adenoma detection. Gastrointest Endosc. 2017 Mar;85(3):574-580. doi: 10.1016/j.gie.2016.08.021. Epub 2016 Aug 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Colonoscopy | Standard colonoscopy without an attachment cap |
| FG001 | Cap Assisted Colonoscopy | A transparent cap will be affixed to tip of the high-definition wide angle colonoscope. Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Colonoscopy | Standard colonoscopy without an attachment cap |
| BG001 | Cap Assisted Colonoscopy | A transparent cap will be affixed to tip of the high-definition wide angle colonoscope. Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of Adenomas | Mean number of adenomas per patient in each group. | Posted | Mean | Standard Deviation | adenoma per patient | duration of colonoscopy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Colonoscopy | Colonoscopy without a cap. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heiko Pohl | VA Medical Center | 8022959362 | 5595 | heiko.pohl@dartmouth.edu |
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| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| duration of colonoscopy |
| Quality of Bowel Preparation | Proportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent). | duration of colonoscopy |
| Withdrawal Time | • Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps. | time of colonoscope withdrawal |
| Ease of Terminal Ileum Intubation | • Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as "easy". Intubation could be rated by the endoscopist as "easy", "slightly difficult", "difficult", or "unable to intubate". | during colonoscopy |
| Real Time Prediction of Polyp Histology | Difference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp | duration of colonoscopy |
| White River Junction |
| Vermont |
| 05009 |
| United States |
| 26126162 | Derived | Pohl H, Bensen SP, Toor A, Gordon SR, Levy LC, Berk B, Anderson PB, Anderson JC, Rothstein RI, MacKenzie TA, Robertson DJ. Cap-assisted colonoscopy and detection of Adenomatous Polyps (CAP) study: a randomized trial. Endoscopy. 2015 Oct;47(10):891-7. doi: 10.1055/s-0034-1392261. Epub 2015 Jun 30. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Indication | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Adenoma Detection Rate | • Adenoma detection rate (ADR), % of patients with at least 1 adenoma | Posted | Count of Participants | Participants | duration of colonoscopy |
|
|
|
| Secondary | Advanced Adenoma Detection Rate | Proportion of patients with advanced adenomas | Posted | Count of Participants | Participants | duration of colonoscopy |
|
|
|
| Secondary | Quality of Bowel Preparation | Proportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent). | Posted | Count of Participants | Participants | duration of colonoscopy |
|
|
|
| Secondary | Withdrawal Time | • Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps. | Posted | Median | Inter-Quartile Range | minutes | time of colonoscope withdrawal |
|
|
|
| Secondary | Ease of Terminal Ileum Intubation | • Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as "easy". Intubation could be rated by the endoscopist as "easy", "slightly difficult", "difficult", or "unable to intubate". | Posted | Count of Participants | Participants | during colonoscopy |
|
|
|
| Secondary | Real Time Prediction of Polyp Histology | Difference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp | Posted | Count of Participants | Participants | duration of colonoscopy |
|
|
|
| 0 |
| 552 |
| 0 |
| 552 |
| EG001 | Cap Assisted Colonoscopy | A transparent cap will be affixed to tip of the high-definition wide angle colonoscope. | 0 | 561 | 0 | 561 |
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| D007417 |
| Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Colonoscopy performed for symptoms (diagnostic) |
|