Recurrence After Gastric and Intestinal Polyp Resection (RAGIP)

December 18, 2025 updated by: Zhaofeng Chen, LanZhou University

Recurrence Rate and Risk Factors After Endoscopic Resection of Gastric and Intestinal Polyps: A Retrospective and Prospective Cohort Study

This is a retrospective and prospective cohort study designed to evaluate the recurrence rate and identify risk factors after endoscopic resection of gastric and intestinal polyps.

BACKGROUND: Gastric and intestinal polyps are common digestive diseases with potential for malignant transformation. Although endoscopic resection is the standard treatment, recurrence rates range from 10-50%, and the mechanisms and risk factors remain unclear.

OBJECTIVES:

Primary: To assess short-term (1-year) and long-term (3-year) recurrence rates after endoscopic polyp resection Secondary: To identify independent risk factors and develop a recurrence risk prediction model

DESIGN: Mixed retrospective-prospective cohort study

  • Retrospective cohort: Patients who underwent polyp resection from 2021-2022, with follow-up data through 2024
  • Prospective cohort: Patients enrolled from 2024-2025, with standardized follow-up through 2028

SETTING: Single tertiary referral center with >10,000 endoscopic polyp resections performed since 2021

PARTICIPANTS: Approximately 1,600-1,800 adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps

FOLLOW-UP:

  • Short-term: 1 year post-resection (±2 months)
  • Long-term: 3 years post-resection (±3 months)

MAIN OUTCOME: Recurrence rate defined as new polyp detection at original or different sites during endoscopic surveillance

POTENTIAL RISK FACTORS: Patient demographics, polyp characteristics (size, number, location, pathology), resection method, Helicobacter pylori status, lifestyle factors, and medication use

EXPECTED IMPACT: Results will inform personalized surveillance strategies and optimize resource allocation for post-polypectomy follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

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

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
        • 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

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps at our tertiary referral center. This includes two cohorts: (1) Retrospective cohort: patients treated from 2021-2022 with existing follow-up data; (2) Prospective cohort: newly enrolled patients from 2024-2025. Eligible participants must have pathologically confirmed polyps (adenomatous, hyperplastic, inflammatory, fundic gland, serrated, or hamartomatous) with negative resection margins. The population represents a diverse group with varying polyp characteristics (size range: <5mm to >20mm; single or multiple polyps; gastric or colorectal locations) and different resection methods (EMR, ESD, snare polypectomy). Excluded are patients with hereditary polyposis syndromes, inflammatory bowel disease, prior gastrointestinal malignancy, or cancer detected at initial resection.

Description

Inclusion Criteria:

  • Age 18 years or older
  • First-time endoscopic examination (gastroscopy or colonoscopy) at the study center
  • Pathologically confirmed polyp of any type (adenomatous, hyperplastic, inflammatory, fundic gland polyp, hamartomatous, serrated lesion)
  • Complete endoscopic resection performed (including EMR, ESD, snare polypectomy, hot biopsy forceps, or argon plasma coagulation)
  • Negative resection margins or complete resection assessed by pathology
  • At least one follow-up endoscopic examination completed (for retrospective cohort) or willingness to complete follow-up (for prospective cohort)
  • Complete baseline clinical data available

Exclusion Criteria:

  • Hereditary polyposis syndromes (familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, juvenile polyposis syndrome)
  • Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Previous history of gastric or colorectal cancer
  • Cancer detected at initial resection (stage T1b or higher)
  • Non-polyp pathology (e.g., submucosal tumors, normal mucosa)
  • Incomplete resection with positive margins that were not re-treated
  • Lost to follow-up with no available surveillance data (for retrospective cohort)
  • Pregnancy at time of enrollment
  • Inability or unwillingness to provide informed consent (for prospective cohort)

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
Retrospective Cohort
Patients who underwent endoscopic polyp resection from January 2021 to December 2022, with retrospective data collection and follow-up through December 2025
Prospective Cohort
Patients undergoing endoscopic polyp resection from October 2024 to December 2025, with prospective standardized data collection and follow-up through December 2028

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term Recurrence Rate at 1 Year
Time Frame: 1 year post-resection (10-14 months acceptable)
New polyp(s) detected by endoscopy and confirmed by pathology at 1-year follow-up. Includes both local recurrence (within 2cm of resection site) and metachronous polyps (>2cm from original site).
1 year post-resection (10-14 months acceptable)
Long-term Recurrence Rate at 3 Years
Time Frame: 3 years post-resection (33-39 months acceptable)
New polyp(s) detected by endoscopy and confirmed by pathology at 3-year follow-up. Includes both local recurrence and metachronous polyps.
3 years post-resection (33-39 months acceptable)
Cumulative Recurrence Rate
Time Frame: Up to 3 years post-resection
Overall recurrence rate combining 1-year and 3-year surveillance results
Up to 3 years post-resection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free Survival Time
Time Frame: Up to 3 years
Measured in months; censored at last follow-up for non-recurrent cases
Up to 3 years
Characteristics of Recurrent Polyps
Time Frame: At 1-year and 3-year follow-up
Descriptive analysis of recurrent polyp features: Number, size, location, and pathological type of recurrent polyps.
At 1-year and 3-year follow-up
Progression to High-grade Dysplasia or Cancer
Time Frame: Up to 3 years
Pathologically confirmed progression: Proportion of participants developing high-grade dysplasia or invasive cancer during follow-up.
Up to 3 years
Re-treatment Rate
Time Frame: Up to 3 years
Proportion of participants requiring repeat endoscopic or surgical treatment: Includes repeat polypectomy, endoscopic resection, or surgical resection
Up to 3 years
Identification of Independent Risk Factors
Time Frame: Analysis conducted after all follow-up completed (2029)
Hazard ratios (HR) and 95% confidence intervals for each significant risk factor
Analysis conducted after all follow-up completed (2029)

Collaborators and Investigators

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

Sponsor

LanZhou University

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

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)

January 20, 2026

Primary Completion (Estimated)

February 25, 2027

Study Completion (Estimated)

February 25, 2029

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDYYczf2025121801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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