The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer

NCT ID: NCT07338643

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-26

Study Completion Date

2028-08-01

Brief Summary

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The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.

Detailed Description

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Conditions

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Abdominal Pain Black Stools Constipation Diarrhea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AI group

AI group

Intervention Type PROCEDURE

Full AI assistance was used throughout the standard colonoscopy procedure.

Series group

Serial group

Intervention Type PROCEDURE

After normal withdrawal of the colonoscope to the splenic flexure during standard colonoscopy, full AI assistance was initiated. The colonoscope was re-entered to the ileocecal region for observation. Any missed lesions were recorded.

Standard group

Standard colonoscopy group

Intervention Type PROCEDURE

The standard colonoscopy procedure was performed as usual

Interventions

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AI group

Full AI assistance was used throughout the standard colonoscopy procedure.

Intervention Type PROCEDURE

Serial group

After normal withdrawal of the colonoscope to the splenic flexure during standard colonoscopy, full AI assistance was initiated. The colonoscope was re-entered to the ileocecal region for observation. Any missed lesions were recorded.

Intervention Type PROCEDURE

Standard colonoscopy group

The standard colonoscopy procedure was performed as usual

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.

Exclusion Criteria

1. Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome
2. Those with intestinal obstruction or malignant tumors
3. Patients with colorectal lesions that need to be treated in stages.
4. Other contraindications for colonoscopy examination.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Limian Er

OTHER

Sponsor Role lead

Responsible Party

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Limian Er

The director of the Endoscopy Department of the Fourth Hospital of Hebei Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li mian Er

Role: STUDY_DIRECTOR

Hebei Medical University Fourth Hospital

Locations

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the Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Central Contacts

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Li mian Er, doctor

Role: CONTACT

13513379068

Zhenzhen Wang, master

Role: CONTACT

13803365602

Facility Contacts

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Li mian Er, Doctor

Role: primary

13513379068

References

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Luo Y, Zhang Y, Liu M, Lai Y, Liu P, Wang Z, Xing T, Huang Y, Li Y, Li A, Wang Y, Luo X, Liu S, Han Z. Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study. J Gastrointest Surg. 2021 Aug;25(8):2011-2018. doi: 10.1007/s11605-020-04802-4. Epub 2020 Sep 23.

Reference Type BACKGROUND
PMID: 32968933 (View on PubMed)

Wu J, Zhang Q, Li X, Bai T, Hou X, Li G, Song J. The Effect of the Second Forward View on the Detection Rate of Sessile Serrated Lesions in the Proximal Colon: A Single-Center Prospective Randomized Controlled Study. Clin Transl Gastroenterol. 2025 Feb 1;16(2):e00805. doi: 10.14309/ctg.0000000000000805.

Reference Type BACKGROUND
PMID: 39688959 (View on PubMed)

Leggett B, Whitehall V. Role of the serrated pathway in colorectal cancer pathogenesis. Gastroenterology. 2010 Jun;138(6):2088-100. doi: 10.1053/j.gastro.2009.12.066.

Reference Type BACKGROUND
PMID: 20420948 (View on PubMed)

Kim HY, Kim SM, Seo JH, Park EH, Kim N, Lee DH. Age-specific prevalence of serrated lesions and their subtypes by screening colonoscopy: a retrospective study. BMC Gastroenterol. 2014 Apr 28;14:82. doi: 10.1186/1471-230X-14-82.

Reference Type BACKGROUND
PMID: 24775268 (View on PubMed)

Huang J, Chan PSF, Pang TWY, Choi P, Chen X, Lok V, Zheng ZJ, Wong MCS. Rate of detection of serrated lesions at colonoscopy in an average-risk population: a meta-analysis of 129,001 individuals. Endosc Int Open. 2021 Mar;9(3):E472-E481. doi: 10.1055/a-1333-1776. Epub 2021 Feb 19.

Reference Type BACKGROUND
PMID: 33655052 (View on PubMed)

王人杰, 张晓兰, 蔡继东, 等. 结直肠息肉的规范化诊疗[J]. 中华胃肠外科杂志, 2024, 27(6): 583-590.

Reference Type BACKGROUND

叶倩云,刘凤斌.大肠息肉发病相关风险因素及方法学研究[J].中华中医药杂志, 2018,33(3):4. DOI:CNKI:SUN:BXYY. 0.2018-03-080.

Reference Type BACKGROUND

Other Identifiers

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2025KS177

Identifier Type: -

Identifier Source: org_study_id

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