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Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate

Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate: a Multicenter Tandem Rondomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07308743
Enrollment
686
Registered
2025-12-30
Start date
2025-12-31
Completion date
2027-07-31
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Adenomas, Colon Polyps, Sessile Serrated Lesion

Keywords

computer-aided detection, proximal adenoma miss rate, Randomized Tandem Colonoscopy Study

Brief summary

This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.

Detailed description

1. Study Centers 1) Nanfang Hospital, Southern Medical Univerisity, Guangzhou, China 2) The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai, China 3) Longgang District People's Hospital of Shenzhen, Shenzhen, China 4) Yangjiang People's Hospital, Yangjiang, China 5) Jiangmen Central Hospital, Jiangmen, China 6) Huizhou Third People's Hospital, Huizhou, China 7) Dongguan Shuixiang Central Hospital, Dongguang, China 8) Pingshan District People's Hospital of Shenzhen, Shenzhen, China 2. Study population 1) Inclusion criteria: 1. Patients age 40-75 years old, regardless of gender 2. Patients presenting for physical examination, colorectal cancer screening or diagnosis 3. Patients voluntarily signs an informed consent form 2) Exclusion criteria: <!-- --> 1. Unable to cooperate ot tolerate colonoscopy 2. History of inflammatory bowel disease 3. History of colorectal cancer 4. Previous colorectal surgery 5. History of recurrent constipation 6. Taking anticoagulant and antiplatelet drugs berfore procedure 7. High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections 8. Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial. 3\) Post-randomization exclusion criteria: <!-- --> 1. Cecum could not be intubated for various reasons 2. Boston Bowel Preparation Scale (BBPS) score of the proximal colon is \<2 3. Study design This is a prospective , multicenter randomized controlled trial comparing the miss rates of proximal colonic lesions (including adenomas, SSLs, and polyps) by computer-aided detection-assisted colonoscopy or conventional colonoscopy. The study will be conducted in the Endoscopy Centre of the participating hospitals. 4. Randomization 1) Eligible patients at each center will be randomized (1:1) to computer-aided detection-assisted colonoscopy first or conventional white light colonoscopy first, followed immediately by the other procedure in tandem fashion by the same endoscopist. The proximal colon is defined as the colonic segment proximal to the hepatic flexure. 2\) Randomization will be performed using computer-generated random sequences in blocks of 6, with stratification by academic level of participation center, experience of endoscopists, and indications of colonoscopy. Patients will be blinded to their group assignment.

Interventions

DEVICEComputer-aided detection-assisted colonoscopy

Computer-aided detection-assisted colonoscopy for detection of colonic polyp

Conventional white-light colonoscopy

Sponsors

The Fifth Affiliated Hospital of Zunyi Medical College
CollaboratorOTHER
Longgang District People's Hospital of Shenzhen
CollaboratorOTHER
Yangjiang People's Hospital
CollaboratorOTHER
Jiangmen Central Hospital
CollaboratorOTHER
Dongguan Shuixiang Central Hospital
CollaboratorUNKNOWN
Pingshan District People's Hospital of shenzhen
CollaboratorUNKNOWN
Huizhou Third People's Hospital
CollaboratorUNKNOWN
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Intervention model description

Prospective randomized design

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients age 40-75 years old, regardless of gender 2. Patients presenting for physical examination, colorectal cancer screening or diagnosis 3. Patients voluntarily signs an informed consent form

Exclusion criteria

1. Unable to cooperate ot tolerate colonoscopy 2. History of inflammatory bowel disease 3. History of colorectal cancer 4. Previous colorectal surgery 5. History of recurrent constipation 6. Taking anticoagulant and antiplatelet drugs berfore procedure 7. High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections 8. Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frameDescription
Proximal adenoma missed rateOne dayThe number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection.

Secondary

MeasureTime frameDescription
Proximal polyp missed rateOne dayThe number of polyps identified during the second right colon inspection divided by the overall number of polyps identified during the first and second right colon inspection.
Proximal SSLs missed rateOne daysThe number of SSLs identified during the second right colon inspection divided by the overall number of SSLs identified during the first and second right colon inspection.
Proximal advanced adenoma missed rateOne dayThe number of advanced adenomas identified during the second right colon inspection divided by the overall number of advanced adenomas identified during the first and second right colon inspection.

Countries

China

Contacts

Primary ContactZelong Han, MD, PhD
hanzelong2025@163.com+86 189-2506-1890
Backup ContactBitao Lin, MD
linbitao1996@163.com+86 137-2532-1385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026