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Not yet recruitingNCT07314554RAGIPUpdated Jun 9, 2026

Recurrence After Gastric and Intestinal Polyp Resection

An observational study in Gastric Polyps, Intestinal Polyps and Colon Polyps, sponsored by LanZhou University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by LanZhou University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Polyps
  • Intestinal Polyps
  • Colon Polyps
  • Colorectal Polyps
  • Adenomatous Polyps
  • Gastric Adenoma and Early Gastric Cancer
  • Colorectal Adenoma

Keywords

  • Polyp recurrence
  • Endoscopic resection
  • Polypectomy
  • Endoscopic mucosal resection
  • Endoscopic submucosal dissection
  • Risk factors
  • Surveillance
  • Follow-up
  • Adenoma
  • Gastric polyp
  • Colorectal polyp
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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)
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. Short-term Recurrence Rate at 1 Year

    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).

    Time frame: 1 year post-resection (10-14 months acceptable)

  2. Long-term Recurrence Rate at 3 Years

    New polyp(s) detected by endoscopy and confirmed by pathology at 3-year follow-up. Includes both local recurrence and metachronous polyps.

    Time frame: 3 years post-resection (33-39 months acceptable)

  3. Cumulative Recurrence Rate

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

    Time frame: Up to 3 years post-resection

Secondary outcomes

  1. Recurrence-free Survival Time

    Measured in months; censored at last follow-up for non-recurrent cases

    Time frame: Up to 3 years

  2. Characteristics of Recurrent Polyps

    Descriptive analysis of recurrent polyp features: Number, size, location, and pathological type of recurrent polyps.

    Time frame: At 1-year and 3-year follow-up

  3. Progression to High-grade Dysplasia or Cancer

    Pathologically confirmed progression: Proportion of participants developing high-grade dysplasia or invasive cancer during follow-up.

    Time frame: Up to 3 years

  4. Re-treatment Rate

    Proportion of participants requiring repeat endoscopic or surgical treatment: Includes repeat polypectomy, endoscopic resection, or surgical resection

    Time frame: Up to 3 years

  5. Identification of Independent Risk Factors

    Hazard ratios (HR) and 95% confidence intervals for each significant risk factor

    Time frame: Analysis conducted after all follow-up completed (2029)

06

Study locations

1 site
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu 730000, China
07

References and documents

Publications

  • Sekiguchi M, Kakugawa Y, Matsumoto M, Matsuda T. A scoring model for predicting advanced colorectal neoplasia in a screened population of asymptomatic Japanese individuals. J Gastroenterol. 2018 Oct;53(10):1109-1119. doi: 10.1007/s00535-018-1433-7. Epub 2018 Jan 22. PubMed 29359244 ↗
  • Brenner H, Chang-Claude J, Jansen L, Knebel P, Stock C, Hoffmeister M. Reduced risk of colorectal cancer up to 10 years after screening, surveillance, or diagnostic colonoscopy. Gastroenterology. 2014 Mar;146(3):709-17. doi: 10.1053/j.gastro.2013.09.001. Epub 2013 Sep 5. PubMed 24012982 ↗
  • Click B, Pinsky PF, Hickey T, Doroudi M, Schoen RE. Association of Colonoscopy Adenoma Findings With Long-term Colorectal Cancer Incidence. JAMA. 2018 May 15;319(19):2021-2031. doi: 10.1001/jama.2018.5809. PubMed 29800214 ↗
  • Martinez ME, Baron JA, Lieberman DA, Schatzkin A, Lanza E, Winawer SJ, Zauber AG, Jiang R, Ahnen DJ, Bond JH, Church TR, Robertson DJ, Smith-Warner SA, Jacobs ET, Alberts DS, Greenberg ER. A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology. 2009 Mar;136(3):832-41. doi: 10.1053/j.gastro.2008.12.007. Epub 2008 Dec 9. PubMed 19171141 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07314554
Lead sponsor
LanZhou University
Responsible party
Zhaofeng Chen (Clinical Professor, LanZhou University) — Principal investigator
First posted
Jan 2, 2026
Start date
Jul 26, 2026 (estimated)
Primary completion
Feb 25, 2027 (estimated)
Completion
Feb 25, 2029 (estimated)
Last update
Jun 9, 2026

Study contacts

Qiangqiang Tian
Contact
tianqq2023@lzu.edu.cn
86+15009460497

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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