Recurrence After Gastric and Intestinal Polyp Resection

NCT07314554 | Not Yet Recruiting

• 1 other identifier: LDYYczf2025121801
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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).

  1 year post-resection (10-14 months acceptable)

• 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.

  3 years post-resection (33-39 months acceptable)

• Cumulative Recurrence Rate

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

  Up to 3 years post-resection

Secondary Outcomes (5)

• Recurrence-free Survival Time

  Up to 3 years

• Characteristics of Recurrent Polyps

  At 1-year and 3-year follow-up

• Progression to High-grade Dysplasia or Cancer

  Up to 3 years

• Re-treatment Rate

  Up to 3 years

• Identification of Independent Risk Factors

  Analysis conducted after all follow-up completed (2029)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Related Publications (4)

• 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.

  PMID: 29359244 BACKGROUND

• 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.

  PMID: 24012982 BACKGROUND

• 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.

  PMID: 29800214 BACKGROUND

• 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.

  PMID: 19171141 BACKGROUND

MeSH Terms

Conditions

Polyposis, Gastric; Intestinal Polyps; Colonic Polyps; Adenomatous Polyps; Stomach Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Qiangqiang Tian

CONTACT

86+15009460497; tianqq2023@lzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)