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Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas

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ClinicalTrials.gov Identifier: NCT03560037
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This study evaluates whether the use of a disposable colonoscope attachment, Endocuff Vision, can increase the detection of sessile serrated adenomas. Participating patients will be randomized to receive either standard colonoscopy or colonoscopy with the Endocuff Vision.

Condition or disease Intervention/treatment Phase
Sessile Serrated Adenoma Device: Endocuff Vision Assisted Colonoscopy Not Applicable

Detailed Description:

Colon cancer remains the second leading cause of death amongst both men and women in the United States(1). With the advent of screening colonoscopy, mortality from colorectal cancer has decreased, and colonoscopy is the current gold standard for colorectal cancer screening and prevention by removing adenomatous polyps.

Different devices have been employed to assist the endoscopist in the detection of colon adenomas, as these lesions serve as precursors to colon neoplasia. One device of interest is the Endocuff Vision. The Endocuff Vision is a disposable device with a single row of soft, hair-like projections that aid in flattening colonic folds during colonoscope withdrawal to increase the detection of colon adenomas. Previous studies have compared endocuff-assisted colonoscopy to standard colonoscopy, and the results have indicated significant improvement in overall adenoma detection rates (ADR)(2-4). All of these studies have focused on the detection of conventional tubular adenomas as primary endpoints. However, there exists an additional serrated adenoma pathway that may give rise to about 15-20% of colon cancers (5). These lesions tend to be flatter with subtler features that make them harder to detect. A recent meta-analysis suggested that the endocuff was more effective at detecting sessile serrated adenomas compared to standard colonoscopy; however, these findings are derived from secondary data analyses (6). To the best of our knowledge, no study to date has examined the sessile serrated adenoma detection rate as a primary endpoint.

Our previous study examined the differences in overall adenoma detection between endocuff-assisted and standard colonoscopy. Although there was no statistical difference in ADR between endocuff-assisted colonoscopy and standard colonoscopy, investigators did observe a numeric difference in sessile serrated adenoma detection rate (SSADR), 16.7% vs 23.8% (p = 0.5) between standard colonoscopy and endocuff-assisted colonoscopy, respectively. Given the previous sample size was calculated to detect differences in overall ADR, the study was not powered to determine whether this observed difference in SSADR was significant.

Therefore, the goal of the proposed study is to compare standard colonoscopy to endocuff-assisted colonoscopy in patients undergoing colonoscopy for colon cancer screening to determine differences in sessile serrated adenoma detection rates.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Use of Endocuff Vision to Increase Detection of Sessile Serrated Adenomas During Screening Colonoscopy
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
No Intervention: Standard Colonoscopy
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
Experimental: Endocuff Vision Assisted Colonoscopy
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Device: Endocuff Vision Assisted Colonoscopy
Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.




Primary Outcome Measures :
  1. Sessile Serrated Adenoma Detection Rate [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    Number of colonoscopies with at least one sessile serrated adenoma divided amongst the total colonoscopies for each intervention.


Secondary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    Number of colonoscopies with at least one adenoma divided amongst the total colonoscopies for each intervention.

  2. Proximal Colon Adenoma Detection Rate [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma divided amongst the total colonoscopies for each intervention.

  3. Mean Number of Adenomas Per Colonoscopy [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    Total adenomas detected in each treatment arm divided amongst the number of patients in each arm

  4. Mean Number of Sessile Serrated Adenomas Per Colonoscopy [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm.

  5. Mean Number of Adenomas Per Positive Colonoscopy [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    The total adenomas detected divided by the number of colonoscopies with at least one adenoma

  6. Mean Number of Sessile Serrated Adenomas Per Positive Colonoscopy [ Time Frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma

  7. Colonoscope Withdrawal Time [ Time Frame: Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    The time it takes to withdraw the colonoscope from the cecum to the end of the examination.

  8. Differences in Quality of Bowel Preparation [ Time Frame: Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. ]
    Measurement of colon preparation based on the validated Boston Bowel Prep Score. Each colon segment (right, transverse, and left colons) will receive a score of 0 (worse) to 3 (best). The sum of each segment will be reported as a total score of 0 (worse) to 9 (best).



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients who present to our outpatient gastroenterology suites for screening colonoscopy.

Exclusion Criteria:

  • Age less than 45 and greater than 85
  • Prior history of colon polyps (hyperplastic polyp, tubular adenoma or sessile serrated adenoma) and colon cancer
  • Patients with inflammatory bowel disease
  • Patients suspected to have colon cancer based on non-invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).
  • Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc., or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon
  • Patients with family history of colon cancer in 1st degree relative below the age of 60
  • Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc., which are associated with an increased risk of colon cancer
  • Patients unable to consent
  • Pregnant patients
  • Incarcerated patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560037


Contacts
Contact: Joseph G Marsano, MD 916-734-3751 jgmarsano@ucdavis.edu

Sponsors and Collaborators
University of California, Davis

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03560037     History of Changes
Other Study ID Numbers: 1164295
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All patient de-identified data that is collected during the clinical trial.
Supporting Materials: Study Protocol
Time Frame: Immediately after publication and ending at 5 years after publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms