Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection

Colonoscopy Clinical Trial

Official title:

Evaluation of Artificial Intelligence for Adenoma Detection in Water Exchange Colonoscopy: the WEAID Randomized Controlled Trial (Water Exchange With Artificial Intelligence-assisted Detection)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173258
• Other study ID #: WEAID
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: December 2023
• Source: Evergreen General Hospital, Taiwan
• Contact: Chi-Liang Cheng
• Phone: 0919768058
• Email: chiliang.cheng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the detected adenoma per colonoscopy (APC) in participants undergoing screening, surveillance, and positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT). There will be two arms in this study: WE water control and water plus artificial intelligence (AI). The main question it aims to answer is whether the addition of AI into water exchange (WE) colonoscopy increases APC than WE alone. The control method will use water instead of air inserted into the colon. The study method will use a commercially available AI system plus water during the procedure. Researchers will compare APCs to see if the addition of AI increases detection of adenomas during WE colonoscopy.

Description:

This will be a multi-site, multi-national, unblinded investigators, prospective Random Control Trial (RCT). Randomization (1:1 to WE alone and WE-AI) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with two arms (WE, WE-AI) to see which one is better at detecting adenomas.

Patient recruitment will be conducted at three hospitals in Italy and Taiwan: Digestive Endoscopy Unit, CTO Hospital, Iglesias, Italy; Digestive Endoscopy and Gastroenterology Unit, Manzoni Hospital, Lecco, Italy; Evergreen General Hospital, Taoyuan, Taiwan. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. The study period is expected to be 3 years (from November 2023 to October 2026).

Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (primary screening, surveillance, or positive FIT or gFOBT). Mode of sedation will include unsedated, on demand sedation, conscious sedation or full sedation with propofol. Randomization will be carried out by computer-generated sequences using a block design (four participants per block).

Control Method: One arm of the study will include sedated/unsedated colonoscopy with water (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Study method: The other arm entail the addition of a commercially available AI system (GI Genius, Medtronic; CAD-EYE, Fujifilm; Endo-AID, Olympus) to the high-definition colonoscopy system. This arm includes sedated/unsedated colonoscopy with AI detection device plus water (WE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 836
• Est. completion date: October 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 45-75 years at average risk for colorectal cancer who plan to undergo colonoscopy for primary screening, postpolypectomy surveillance, and individuals with positive fecal immunochemical test or guaiac fecal occult blood test results.

Exclusion Criteria:

• Patients with a history of inflammatory bowel disease

• Patients with hereditary colorectal cancer syndrome or serrated polyposis syndrome

• Patients with a personal history of colorectal cancer

• Patients with a history of colorectal resection

• Patients with colonic stricture

• Patient with severe comorbid illnesses rendering polypectomy unsafe

• Patients with colonoscopy contraindications (e.g., acute diverticulitis or toxic megacolon)

• Therapeutic colonoscopy (e.g., hemostasis, removal of a large polyp)

• Emergent colonoscopy

• Pregnant women or those planning pregnancy

• Patients unwilling to participate in the study

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Polyp
• Colonoscopy

Intervention

Device:
• Water exchange alone
During the insertion phase of water exchange colonoscopy, the air pump will be turned off, while the colon will be irrigated with warm-to-touch water using a flushing pump. The water exchange approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion. Upon reaching the cecum, where most of the water is suctioned to collapse the cecal lumen, the air pump will be opened. Withdrawal from the cecum will begin in the left lateral position. Similar withdrawal techniques with adequate luminal distention and comprehensive examination behind the folds will be emphasized. Any position change away from the original left lateral position in any colon segment during the withdrawal phase will be recorded. Tandem examination of specific colon segments, including the right colon, either in the standard modality or retroflexion, is prohibited.
• Water exchange plus Artificial Intelligence (AI)
Similar water exchange technique as the active comparator will be employed during insertion. Similar withdrawal inspection techniques as the active comparator will be used. During withdrawal phase, commercially available AI system (GI Genius, Medtronic, USA; CAD-EYE, Fujifilm, EU and Taiwan; Endo-AID, Olympus, EU and Taiwan) will be activated, providing a bounding box as output any time a lesion that is suspected to be a polyp is recognized by the AI device. False positive activation is defined as the identification by AI systems of an area during the withdrawal phase that is not deemed to be a colorectal lesion after re-examination by the colonoscopist. Real-time flagging of FP activation will be recorded by investigators and study staff.

Locations

Country	Name	City	State
Italy	CTO Hospital	Iglesias
Italy	Manzoni Hospital	Lecco
Taiwan	Chi-Liang Cheng	Taoyuan

Sponsors (4)

Lead Sponsor	Collaborator
Evergreen General Hospital, Taiwan	Digestive Endoscopy and Gastroenterology Unit, Manzoni Hospital, Lecco, Italy, Digestive Endoscopy Unit, CTO Hospital, Iglesias, Italy, The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA

Countries where clinical trial is conducted

Italy,  Taiwan, 

References & Publications (16)

Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10. — View Citation

Denis B, Sauleau EA, Gendre I, Piette C, Bretagne JF, Perrin P. Measurement of adenoma detection and discrimination during colonoscopy in routine practice: an exploratory study. Gastrointest Endosc. 2011 Dec;74(6):1325-36. doi: 10.1016/j.gie.2011.07.038. Epub 2011 Sep 29. — View Citation

Hassan C, Badalamenti M, Maselli R, Correale L, Iannone A, 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, Repici A. Computer-aided detection-assisted colonoscopy: classification and relevance of false positives. Gastrointest Endosc. 2020 Oct;92(4):900-904.e4. doi: 10.1016/j.gie.2020.06.021. Epub 2020 Jun 16. — View Citation

Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11. — View Citation

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Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15. — View Citation

Kaltenbach T, Gawron A, Meyer CS, Gupta S, Shergill A, Dominitz JA, Soetikno RM, Nguyen-Vu T, A Whooley M, Kahi CJ. Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1883-1889.e1. doi: 10.1016/j.cgh.2021.02.028. Epub 2021 Feb 19. — View Citation

Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. United European Gastroenterol J. 2017 Apr;5(3):309-334. doi: 10.1177/2050640617700014. Epub 2017 Mar 16. — View Citation

Mori Y, Wang P, Loberg M, Misawa M, Repici A, Spadaccini M, Correale L, Antonelli G, Yu H, Gong D, Ishiyama M, Kudo SE, Kamba S, Sumiyama K, Saito Y, Nishino H, Liu P, Glissen Brown JR, Mansour NM, Gross SA, Kalager M, Bretthauer M, Rex DK, Sharma P, Berzin TM, Hassan C. Impact of Artificial Intelligence on Colonoscopy Surveillance After Polyp Removal: A Pooled Analysis of Randomized Trials. Clin Gastroenterol Hepatol. 2023 Apr;21(4):949-959.e2. doi: 10.1016/j.cgh.2022.08.022. Epub 2022 Aug 28. — View Citation

Nehme F, Coronel E, Barringer DA, Romero LG, Shafi MA, Ross WA, Ge PS. Performance and attitudes toward real-time computer-aided polyp detection during colonoscopy in a large tertiary referral center in the United States. Gastrointest Endosc. 2023 Jul;98(1):100-109.e6. doi: 10.1016/j.gie.2023.02.016. Epub 2023 Feb 18. — View Citation

Patel SG, May FP, Anderson JC, Burke CA, Dominitz JA, Gross SA, Jacobson BC, Shaukat A, Robertson DJ. Updates on Age to Start and Stop Colorectal Cancer Screening: Recommendations From the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2022 Jan;162(1):285-299. doi: 10.1053/j.gastro.2021.10.007. Epub 2021 Nov 15. Erratum In: Gastroenterology. 2022 Jul;163(1):339. — View Citation

Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available. — View Citation

Saftoiu A, Hassan C, Areia M, Bhutani MS, Bisschops R, Bories E, Cazacu IM, Dekker E, Deprez PH, Pereira SP, Senore C, Capocaccia R, Antonelli G, van Hooft J, Messmann H, Siersema PD, Dinis-Ribeiro M, Ponchon T. Role of gastrointestinal endoscopy in the screening of digestive tract cancers in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Apr;52(4):293-304. doi: 10.1055/a-1104-5245. Epub 2020 Feb 12. — View Citation

Spadaccini M, Hassan C, Alfarone L, Da Rio L, Maselli R, Carrara S, Galtieri PA, Pellegatta G, Fugazza A, Koleth G, Emmanuel J, Anderloni A, Mori Y, Wallace MB, Sharma P, Repici A. Comparing the number and relevance of false activations between 2 artificial intelligence computer-aided detection systems: the NOISE study. Gastrointest Endosc. 2022 May;95(5):975-981.e1. doi: 10.1016/j.gie.2021.12.031. Epub 2022 Jan 4. — View Citation

Tang CP, Lin TL, Hsieh YH, Hsieh CH, Tseng CW, Leung FW. Polyp detection and false-positive rates by computer-aided analysis of withdrawal-phase videos of colonoscopy of the right-sided colon segment in a randomized controlled trial comparing water exchange and air insufflation. Gastrointest Endosc. 2022 Jun;95(6):1198-1206.e6. doi: 10.1016/j.gie.2021.12.020. Epub 2021 Dec 30. — View Citation

Wieszczy P, Bugajski M, Januszewicz W, Rupinska M, Szlak J, Pisera M, Turkot MH, Rupinski M, Wojciechowska U, Didkowska J, Regula J, Kaminski MF. Comparison of Quality Measures for Detection of Neoplasia at Screening Colonoscopy. Clin Gastroenterol Hepatol. 2023 Jan;21(1):200-209.e6. doi: 10.1016/j.cgh.2022.03.023. Epub 2022 Mar 24. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma per colonoscopy	Adenoma per colonoscopy is calculated as the total number of adenomas detected divided by the total number of colonoscopies performed in the subjects undergoing a complete colonoscopy.	One week (after the colonoscopy procedure, when pathology report is released)
Primary	Adenoma detection rate	The percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed.	One week (after the colonoscopy procedure, when pathology report is released)