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

Sessile Serrated Adenoma Clinical Trial

Official title:

Use of Endocuff Vision to Increase Detection of Sessile Serrated Adenomas During Screening Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560037
• Other study ID #: 1164295
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Sessile Serrated Adenoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (6)

Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166. — View Citation

Chin M, Karnes W, Jamal MM, Lee JG, Lee R, Samarasena J, Bechtold ML, Nguyen DL. Use of the Endocuff during routine colonoscopy examination improves adenoma detection: A meta-analysis. World J Gastroenterol. 2016 Nov 21;22(43):9642-9649. doi: 10.3748/wjg.v22.i43.9642. — View Citation

De Palma GD, Giglio MC, Bruzzese D, Gennarelli N, Maione F, Siciliano S, Manzo B, Cassese G, Luglio G. Cap cuff-assisted colonoscopy versus standard colonoscopy for adenoma detection: a randomized back-to-back study. Gastrointest Endosc. 2018 Jan;87(1):232-240. doi: 10.1016/j.gie.2016.12.027. Epub 2017 Jan 9. — View Citation

Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014. — View Citation

Obuch JC, Ahnen DJ. Colorectal Cancer: Genetics is Changing Everything. Gastroenterol Clin North Am. 2016 Sep;45(3):459-76. doi: 10.1016/j.gtc.2016.04.005. — View Citation

Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sessile Serrated Adenoma Detection Rate	Number of colonoscopies with at least one sessile serrated adenoma divided amongst the total colonoscopies for each intervention.	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.
Secondary	Adenoma Detection Rate	Number of colonoscopies with at least one adenoma divided amongst the total colonoscopies for each intervention.	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.
Secondary	Proximal Colon Adenoma Detection Rate	Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma divided amongst the total colonoscopies for each intervention.	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.
Secondary	Mean Number of Adenomas Per Colonoscopy	Total adenomas detected in each treatment arm divided amongst the number of patients in each arm	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.
Secondary	Mean Number of Sessile Serrated Adenomas Per Colonoscopy	Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm.	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.
Secondary	Mean Number of Adenomas Per Positive Colonoscopy	The total adenomas detected divided by the number of colonoscopies with at least one adenoma	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.
Secondary	Mean Number of Sessile Serrated Adenomas Per Positive Colonoscopy	The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma	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.
Secondary	Colonoscope Withdrawal Time	The time it takes to withdraw the colonoscope from the cecum to the end of the examination.	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.
Secondary	Differences in Quality of Bowel Preparation	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).	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.