Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection
NCT ID: NCT06173258
Last Updated: 2025-02-14
Study Results
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Basic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2023-12-18
2025-01-05
Brief Summary
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Detailed Description
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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 (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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Water exchange alone
Residual air in the colon will be removed, 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.
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 (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.
Water exchange plus Artificial intelligence (AI)
During colonoscopic insertion, residual air in the colon will be removed, 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. A commercially available AI system (CAD-EYE, Fujifilm, used in Taiwan; Endo-AID, Olympus used in Italy) will be employed. During AI-assisted procedures, the AI will be activated during the withdrawal phase of the procedure, providing a bounding box as output any time a lesion that is suspected to be a polyp is recognized by the AI 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 (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.
Interventions
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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 (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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
45 Years
75 Years
ALL
Yes
Sponsors
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Evergreen General Hospital, Taiwan
OTHER
Digestive Endoscopy Unit, CTO Hospital, Iglesias, Italy
UNKNOWN
The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
UNKNOWN
Responsible Party
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Principal Investigators
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Sergio Cadoni, MD
Role: PRINCIPAL_INVESTIGATOR
Endoscopy Digestive Unit, CTO Hospital, Iglesias, Italy
Locations
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CTO Hospital
Iglesias, , Italy
Chi-Liang Cheng
Taoyuan District, , Taiwan
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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WEAID
Identifier Type: -
Identifier Source: org_study_id
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