Study on the Association Between Serrated Polyps and Metachronous Advanced Colorectal Neoplastic Lesions

June 25, 2026 updated by: Changhai Hospital

Risk Factors for Metachronous Advanced Colorectal Lesions After Endoscopic Resection of Serrated Lesions

This study aims to explore the risk factors associated with the development of ACN and same-site ACN in patients with SP, thereby informing the optimization of clinical surveillance strategies

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients who underwent at least two surveillance colonoscopies at the Digestive Endoscopy Center of Shanghai Changhai Hospital between 2000 and 2025 were enrolled as study participants

Description

Inclusion Criteria:

  • Adult patients aged > 18 years;At least one SP detected during the index colonoscopy and pathologically confirmed as TSA or SSL (according to the 2019 WHO classification criteria);Underwent complete polypectomy during the index colonoscopy;Received regular follow-up at Changhai Hospital, with an interval of ≥ 6 months between the index and follow-up colonoscopies;Complete clinical and pathological data.

Exclusion Criteria:

  • Incomplete colonoscopy or failed cecal intubation;Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score < 6 or a score < 2 in any bowel segment;Withdrawal time < 6 minutes;Diagnosis of hereditary cancer syndromes, such as familial adenomatous polyposis (FAP) or Lynch syndrome;Concurrent inflammatory bowel disease (IBD) or indeterminate colitis;History of colorectal cancer or other malignancies;Incomplete clinical or pathological records.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with serrated polyps at index colonoscopy and ACN at surveillance
Patients with serrated polyps at index colonoscopy and no ACN at surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of metachronous ACN
Time Frame: At least 6 months after index colonoscopy
At least 6 months after index colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • [1] SIEGEL R L, MILLER K D, JEMAL A. Cancer statistics, 2020[J/OL]. CA: A Cancer Journal for Clinicians, 2020, 70(1): 7-30. DOI:10.3322/caac.21590. [2] NAGTEGAAL I D, ODZE R D, KLIMSTRA D, et al. The 2019 WHO classification of tumours of the digestive system[J/OL]. Histopathology, 2020, 76(2): 182-188. DOI:10.1111/his.13975. [3] LI D, LIU L, FEVRIER H B, et al. Increased Risk of Colorectal Cancer in Individuals With a History of Serrated Polyps[J/OL]. Gastroenterology, 2020, 159(2): 502-511.e2. DOI:10.1053/j.gastro.2020.04.004. [4] ERICHSEN R, BARON J A, HAMILTON-DUTOIT S J, et al. Increased Risk of Colorectal Cancer Development Among Patients With Serrated Polyps[J/OL]. Gastroenterology, 2016, 150(4): 895-902.e5. DOI:10.1053/j.gastro.2015.11.046. [5] BAILE-MAXÍA S, MANGAS-SANJUÁN C, LADABAUM U, et al. Risk factors for metachronous colorectal cancer or advanced lesions after endoscopic resection of serrated polyps: a systematic review and meta-analysis[J/OL]. Gastrointestinal Endoscopy, 2024, 100(4): 605-615.e14. DOI:10.1016/j.gie.2024.05.021. [6] TRIVEDI M, GODIL S, DEMB J, et al. Baseline Characteristics and Longitudinal Outcomes of Traditional Serrated Adenomas: A Cohort Study[J/OL]. Clinical Gastroenterology and Hepatology, 2023, 21(6): 1637-1645. DOI:10.1016/j.cgh.2022.09.030. [7] HE D, WANG K, ZHANG Y, et al. Risk of advanced neoplasia after removal of colorectal adenomas with high-grade dysplasia[J/OL]. Surgical Endoscopy, 2024, 38(7): 3783-3798. DOI:10.1007/s00464-024-10898-5. [8] BLEIJENBERG A, KLOTZ D, LØBERG M, et al. Implications of different guidelines for surveillance after serrated polyp resection in United States of America and Europe[J/OL]. Endoscopy, 2019, 51(08): 750-758. DOI:10.1055/a-0916-8598.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 34435353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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