Trainee Participation Increases Colon Adenoma Detection Rate

Colonic Polyp Clinical Trial

— ADR  

Official title:

Trainee Participation Increases Colon Adenoma Detection Rate: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908229
• Other study ID #: ADR01
• Status: Completed
• Phase: N/A
• Start date: April 5, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: March 2020
• Source: Ospedali Riuniti di Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well—designed randomized controlled trials are lacking.

The study objective is to examine whether fellow participation during screening, surveillance, or diagnostic colonoscopy influence overall, size-specific, or location-specific adenoma or polyp detection rate.

It will be planned to enroll 812 patients (406 per arms) within 1 year. Adenoma detection rate will be the primary outcome.

Description:

Background Colonoscopy is instrumental in colon cancer prevention as through polypectomy it may interfere with the adenoma-carcinoma sequence, thus resulting in a clear survival benefit.

However, not all adenomatous polyps are identified during a colonoscopy. The overall false-negative ("miss") rate for colonic adenomas is estimated to be as high as 24%, according to studies of same-day, tandem colonoscopies. In addition, flat and depressed lesions often remain undetected during white-light colonoscopy.

Low-cost optimization of existing resources, such as use of a second observer or water-aided colonoscopy, were recently found to be able to significantly increase colon adenoma detection rate (ADR).

Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well—designed randomized controlled trials (RCTs) are lacking.

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Technical procedure In the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations.

In the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending.

During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions.

Colonoscopies will be performed by using only high-definition white-light (HDWL) scopes (Olympus 180 series CF H180).

Bowel preparation will be uniform and consist of 4 L of polyethylene glycol. All detected lesions will be endoscopically removed and samples will be sent to pathologists for histological diagnosis.

Treatment strategy Patients complying with the eligibility criteria will be randomized in a 1:1 fashion to undergo colonoscopy performed by a trainee (under attending physician supervision) or colonoscopy performed by an experienced physician.

Sample size calculation and statistical considerations On the basis of previous retrospective comparative reports, the study is designed to detect an increase in ADR by 8%. Therefore, 812 patients (406 per arm) will be required to have a 80% power to detect the target difference at a 0.05 significance level (two sided). The primary endpoint will be ADR. In order to collect the estimated sample size, up to 1 year of recruiting will be needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: January 10, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing colonoscopy.

Exclusion Criteria:

• Age under 18 years

• Familial history of polyposis syndrome (familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, juvenile polyposis).

• Incomplete colonoscopy

• Inflammatory bowel disease

• Refusal to provide informed consent.

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Procedure:
• Trainee colonoscopy
Colonoscopy performed by trainee
• Experienced physician colonoscopy
Experienced physician colonoscopy

Locations

Country	Name	City	State
Italy	Ospedale di Brindisi	Brindisi
Italy	Ospedali Riuniti Foggia	Foggia
Italy	Ospedale di San Severo	San Severo	Out Of USA Or Canada
Italy	Ospedale di Taranto	Taranto	Out Of USA Or Canada

Sponsors (1)

Lead Sponsor	Collaborator
Ospedali Riuniti di Foggia

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Buchner AM, Shahid MW, Heckman MG, Diehl NN, McNeil RB, Cleveland P, Gill KR, Schore A, Ghabril M, Raimondo M, Gross SA, Wallace MB. Trainee participation is associated with increased small adenoma detection. Gastrointest Endosc. 2011 Jun;73(6):1223-31. doi: 10.1016/j.gie.2011.01.060. Epub 2011 Apr 8. — View Citation

Facciorusso A, Triantafyllou K, Murad MH, Prokop LJ, Tziatzios G, Muscatiello N, Singh S. Compared Abilities of Endoscopic Techniques to Increase Colon Adenoma Detection Rates: A Network Meta-analysis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2439-2454.e25. doi: 10.1016/j.cgh.2018.11.058. Epub 2018 Dec 6. — View Citation

Gianotti RJ, Oza SS, Tapper EB, Kothari D, Sheth SG. A Longitudinal Study of Adenoma Detection Rate in Gastroenterology Fellowship Training. Dig Dis Sci. 2016 Oct;61(10):2831-2837. doi: 10.1007/s10620-016-4228-9. Epub 2016 Jul 12. — View Citation

Nishizawa T, Suzuki H, Takahashi M, Kaneko H, Fujiyama Y, Komatsu H, Nagumo H, Tanaka S, Hibi T. Trainee participation during colonoscopy adversely affects polyp and adenoma detection rates. Digestion. 2011;84(3):245-6. doi: 10.1159/000330736. Epub 2011 Sep 7. — View Citation

Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. — View Citation

Rex DK. Maximizing detection of adenomas and cancers during colonoscopy. Am J Gastroenterol. 2006 Dec;101(12):2866-77. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		12 months
Secondary	Advanced adenoma detection rate		12 months
Secondary	Polyp detection rate		12 months
Secondary	Sessile serrated adenoma detection rate		12 months
Secondary	Adenoma per colonoscopy rate		12 months