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Clinical Trials/NCT07314554
NCT07314554
Not yet recruiting
Not Applicable

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

LanZhou University1 site in 1 country2,000 target enrollmentStarted: January 20, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
LanZhou University
Enrollment
2,000
Locations
1
Primary Endpoint
Short-term Recurrence Rate at 1 Year

Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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).

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.

Cumulative Recurrence Rate

Time Frame: Up to 3 years post-resection

Overall recurrence rate combining 1-year and 3-year surveillance results

Secondary Outcomes

  • Characteristics of Recurrent Polyps(At 1-year and 3-year follow-up)
  • Identification of Independent Risk Factors(Analysis conducted after all follow-up completed (2029))
  • Recurrence-free Survival Time(Up to 3 years)
  • Progression to High-grade Dysplasia or Cancer(Up to 3 years)
  • Re-treatment Rate(Up to 3 years)

Investigators

Sponsor
LanZhou University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhaofeng Chen

Clinical Professor

LanZhou University

Study Sites (1)

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