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

NCT07678788 | Not Yet Recruiting

• 1 other identifier: 34435353
• Study Type: observational
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sessile Serrated Lesion; Serrated Polyp

Outcome Measures

Primary Outcomes (1)

• The occurrence of metachronous ACN

  At least 6 months after index colonoscopy

Study Arms (2)

Patients with serrated polyps at index colonoscopy and ACN at surveillance

Patients with serrated polyps at index colonoscopy and no ACN at surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Related Publications (1)

• [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.

  BACKGROUND

Central Study Contacts

Yu Bai, M.D

CONTACT

+8619280762294; 19851132340@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share