Abdominal PainNCT07338643
The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer
An observational study of Abdominal Pain and Black Stools, run by Limian Er at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Pain, Black Stools, Constipation
- What is being tested?
- AI group, Serial group and Standard colonoscopy group
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2026to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea
Who may be able to join
- 1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Li mian Er, Doctor, 13513379068, Hbsyelm@163.com
About this study
Official title: The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer: A Multicenter Randomized Controlled Study
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.
- Conditions
- Abdominal Pain, Black Stools, Constipation, Diarrhea
- Being tested
- AI group, Serial group, Standard colonoscopy group
- Medical subject headings
- Abdominal Pain, Melena, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI groupProcedure or surgery
Full AI assistance was used throughout the standard colonoscopy procedure.
Serial groupProcedure or surgery
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 colonoscopy groupProcedure or surgery
The standard colonoscopy procedure was performed as usual
| Study group | Role | What they receive |
|---|---|---|
| AI group | Not described Receives: Procedure: AI group | |
| Series group | Not described Receives: Procedure: Serial group | |
| Standard group | Not described Receives: Procedure: Standard colonoscopy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The proportion of patients who have at least one adenoma detected during colonoscopy examination
Measured: Day 1
Average adenoma detection rate
The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start26 Feb 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limian Er
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Limian Er, Hebei Medical University Fourth Hospital
- Investigators
- Li mian Er, Study director, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338643
- Sponsor's protocol ID
- 2025KS177
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32968933Wu 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.
PubMed 39688959Leggett 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.
PubMed 20420948Kim 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.
PubMed 24775268Huang 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.
PubMed 33655052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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07338643
- Acronym / sponsor ID
- 2025KS177
- Conditions
- Abdominal Pain, Black Stools, Constipation, Diarrhea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Limian ErUniversity, hospital or other
- Study start
- 26 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI group | – | Procedure: AI group |
| Series group | – | Procedure: Serial group |
| Standard group | – | Procedure: Standard colonoscopy group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea
Key inclusion criteria (1 listed)
- 1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI groupFull AI assistance was used throughout the standard colonoscopy procedure. | Procedure or surgery | AI group |
| Serial groupAfter 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. | Procedure or surgery | Series group |
| Standard colonoscopy groupThe standard colonoscopy procedure was performed as usual | Procedure or surgery | Standard group |
Primary outcome
Adenoma detection rate
Time frame: Day 1
The proportion of patients who have at least one adenoma detected during colonoscopy examination
Average adenoma detection rate
Time frame: Day 1
The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 32968933Luo 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.
- Background: PubMed 39688959Wu 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.
- Background: PubMed 20420948Leggett 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.
- Background: PubMed 24775268Kim 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.
- Background: PubMed 33655052Huang 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.
- Background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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li mian Er study director
Hebei Medical University Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain and Black Stools, run by Limian Er at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li mian Er, doctor (13513379068, Hbsyelm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338643, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.