Impact of AI on Trainee ADR

Colorectal Cancer Clinical Trial

Official title:

Impact of Artificial Intelligence on Trainee Adenoma Detection Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423964
• Other study ID #: HS-21-00094
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2023
• Source: University of Southern California
• Contact: Jessica Serna, BS
• Phone: 323-409-6939
• Email: Jessica.Serna[@]med.usce.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adenoma detection rate (ADR) is a validated quality metric for colonoscopy with higher ADR correlated with improved colorectal cancer outcomes. Artificial intelligence (AI) can automatically detect polyps on the video monitor which may allow endoscopists in training to improve their ADR. Objective and Purpose of the study: Measure the effect of AI in a prospective, randomized manner to determine its impact on ADR of Gastroenterology trainees.

Description:

Our objective is to determine the impact of AI on the adenoma detection rate of Gastroenterology trainees. The secondary aim of this quality improvement study is to determine the impact of AI based endoscopy on the rate of recording of quality improvement metrics versus historical performance in our program. Fellows will undergo educational session prior to the start of study, describing commonly used metrics for assessing quality of colonoscopy and how to use the artificial intelligence software. Gastroenterology fellows will be consented for the study prior to initiation. The fellows will be randomized on a daily basis to perform colonoscopies in a room. Outcomes will measure the effects of AI in fellows

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All Gastroenterology fellows at USC performing Endoscopies will be included in the study.

Exclusion Criteria:

• If fellows refuse informed consent they will be excluded.
• Procedures performed in the intensive care unit or the operating room will not be counted toward the study metrics as the AI system will only be available in the endoscopy unit.
• If procedures are performed only by faculty, in which the fellow is not the primary operator, they will not be used for study metrics.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colorectal Cancer

Intervention

Diagnostic Test:
• AI use in Endoscopy Room
The use of AI versus no AI in comparing the detection of adenomas during Endoscopy procedures.

Other:
• Non-AI use Standard of Care endoscopy room
Non-AI use in comparing the detection of adenomas during Endoscopy procedures.

Locations

Country	Name	City	State
United States	LAC+USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (11)

Abadir AP, Ali MF, Karnes W, Samarasena JB. Artificial Intelligence in Gastrointestinal Endoscopy. Clin Endosc. 2020 Mar;53(2):132-141. doi: 10.5946/ce.2020.038. Epub 2020 Mar 30. — View Citation

Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068. — View Citation

Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086. — View Citation

Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12. — View Citation

Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667. — View Citation

Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, Ferrara E, Spadaccini M, Alkandari A, Fugazza A, Anderloni A, Galtieri PA, Pellegatta G, Carrara S, Di Leo M, Craviotto V, Lamonaca L, Lorenzetti R, Andrealli A, Antonelli G, Wallace M, Sharma P, Rosch T, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2):512-520.e7. doi: 10.1053/j.gastro.2020.04.062. Epub 2020 May 1. — View Citation

Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6. — View Citation

Siegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1. — View Citation

Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18. — View Citation

Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701. — View Citation

Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average adenoma detection rate	Adenoma detection rate with and without AI	Throughout study, an average of 2 years
Secondary	Average of polyps detection rate	Polyp detection rate with and without AI	Through out study, an average of 2 years