The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer
1 other identifier
observational
1,200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 14, 2026
CompletedStudy Start
First participant enrolled
February 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
January 14, 2026
January 1, 2026
2.4 years
December 18, 2025
January 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Adenoma detection rate
The proportion of patients who have at least one adenoma detected during colonoscopy examination
Day 1
Average adenoma detection rate
The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.
Day 1
Study Arms (3)
AI group
Series group
Standard group
Interventions
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.
The standard colonoscopy procedure was performed as usual
Eligibility Criteria
Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea
You may qualify if:
- Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.
You may not qualify if:
- Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome
- Those with intestinal obstruction or malignant tumors
- Patients with colorectal lesions that need to be treated in stages.
- Other contraindications for colonoscopy examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Limian Erlead
Study Sites (1)
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Related Publications (7)
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.
PMID: 32968933BACKGROUNDWu 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.
PMID: 39688959BACKGROUNDLeggett 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.
PMID: 20420948BACKGROUNDKim 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.
PMID: 24775268BACKGROUNDHuang 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.
PMID: 33655052BACKGROUND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.
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Li mian Er
Hebei Medical University Fourth Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The director of the Endoscopy Department of the Fourth Hospital of Hebei Medical University
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 14, 2026
Study Start
February 26, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
January 14, 2026
Record last verified: 2026-01