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Risk of Metachronous Advanced Colorectal Neoplastic Among Individuals With Varying Numbers of Non-Advanced Adenomas Detected During Screening Colonoscopy

NCT ID: NCT07302139

Last Updated: 2025-12-24

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

COMPLETED

Total Enrollment

2955 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-09-30

Brief Summary

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A retrospective observational study to evaluate the risk of metachronous advanced colorectal neoplastic (ACRN) among individuals with varying numbers of non-advanced adenomas (NAA) detected during screening colonoscopy

Detailed Description

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Colorectal cancer (CRC) is the third most commonly diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with increasing westernization of diet and lifestyle, both the incidence and prevalence of CRC in China have risen sharply. CRC has become the most common gastrointestinal malignancy in the country, ranking second in incidence and fifth in mortality among all cancers. Screening colonoscopy and appropriate surveillance intervals can substantially reduce CRC-related deaths.

The latest 2020 U.S. Multi-Society Task Force (USMSTF) guidelines classify patients with 1-2 non-advanced adenomas (NAAs), 3-4 NAAs, and \>4 NAAs as having low-, intermediate-, and high-risk colonoscopic findings, respectively, and recommend surveillance intervals of 7-10 years, 3-5 years, and 3 years for these groups. However, accumulating evidence suggests that the risk of developing metachronous advanced colorectal neoplastic lesions (ACRN) in individuals with 3-4 NAAs may be comparable to those with only 1-2 NAAs, raising concerns regarding the appropriateness of current surveillance recommendations.

Using a real-world, endoscopy database, this study systematically evaluates the association between different NAA counts and the subsequent risk of ACRN, providing evidence to inform optimization of post-polypectomy surveillance intervals.

Conditions

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Colorectal Adenoma

Keywords

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Screening colonoscopy Surveillance Advanced colorectal adenoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Individuals with <3 NAAs detected during screening colonoscopy

Individuals with \<3 non-advanced adenomas detected during screening colonoscopy

No Intervention: Observational Cohort

Intervention Type OTHER

No Intervention: Observational Cohort

Individuals with 3-4 NAAs detected during screening colonoscopy

Individuals with 3-4 non-advanced adenomas detected during screening colonoscopy

No Intervention: Observational Cohort

Intervention Type OTHER

No Intervention: Observational Cohort

Individuals with >4 NAAs detected during screening colonoscopy

Individuals with \>4 non-advanced adenomas detected during screening colonoscopy

No Intervention: Observational Cohort

Intervention Type OTHER

No Intervention: Observational Cohort

Interventions

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No Intervention: Observational Cohort

No Intervention: Observational Cohort

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First-time screening colonoscopy
* Only non-advanced adenomas (no villous features, no high-grade dysplasia, and diameter \<10 mm) were detected during first-time screening colonoscopy
* Individuals with at least one surveillance colonoscopy
* Complete electronic medical record and pathology information

Exclusion Criteria

* Inadequate bowel preparation (BBPS \< 6)
* Emergency colonoscopy
* History of colorectal cancer
* Incomplete pathology information or incompletely resected polyps
* Screening colonoscopies performed by endoscopists with a low dynamic adenoma detection rate (ADR \< 15%)
* Follow-up duration \< 6 months
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danian Ji, M.D.

Role: STUDY_DIRECTOR

Huadong Hospital

Locations

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Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2025K369

Identifier Type: -

Identifier Source: org_study_id