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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Adenomas; Colon Polyps; Sessile Serrated Lesion
• Intervention / Treatment: Device: Computer-aided detection-assisted colonoscopy; Procedure: Conventional white-light 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.

• Study Type: Interventional
• Enrollment (Estimated): 686
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zelong Han, MD, PhD; Phone Number: +86 189-2506-1890; Email: hanzelong2025@163.com
• Study Contact Backup: Name: Bitao Lin, MD; Phone Number: +86 137-2532-1385; Email: linbitao1996@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
      • Contact: Zelong Han, MD, PhD; Phone Number: +86 189-2506-1890; Email: hanzelong2025@163.com
      • Contact: Bitao Lin, MD; Phone Number: +86 137-2532-1385; Email: linbitao1996@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-aided detection-assisted colonoscopy; Tandem colonoscopy of proximal colon assisted with computer-aided detection system followed by conventional white-light colonoscopy	Device: Computer-aided detection-assisted colonoscopy; Computer-aided detection-assisted colonoscopy for detection of colonic polyp
Active Comparator: Conventional white-light colonoscopy; Tandem conventional white-light colonoscopy of proximal colon followed by usual computer-aided detection-assisted colonoscopy	Procedure: Conventional white-light colonoscopy; Conventional white-light colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal adenoma missed rate	The 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.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal polyp missed rate	The 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.	One day
Proximal SSLs missed rate	The 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.	One days
Proximal advanced adenoma missed rate	The 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.	One day

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Collaborators: Jiangmen Central Hospital; The Fifth Affiliated Hospital of Zunyi Medical College; Huizhou Third People's Hospital; Yangjiang People's Hospital; Longgang District People's Hospital of Shenzhen; Dongguan Shuixiang Central Hospital; Pingshan District People's Hospital of shenzhen

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: computer-aided detection; proximal adenoma miss rate; Randomized Tandem Colonoscopy Study
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Pathological Conditions, Signs and Symptoms; Colonic Polyps
• Other Study ID Numbers: NFEC-2025-679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No