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Not yet recruiting NCT07314554

Recurrence After Gastric and Intestinal Polyp Resection

Observational Gastric Polyps Intestinal Polyps Colon Polyps Colorectal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastric Polyps, Intestinal Polyps, Colon Polyps, Colorectal Polyps. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Short-term Recurrence Rate at 1 Year [Time frame: 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)]
  • Cumulative Recurrence Rate [Time frame: Up to 3 years post-resection]
Secondary outcome measures (5)
  • Recurrence-free Survival Time [Time frame: Up to 3 years]
  • Characteristics of Recurrent Polyps [Time frame: At 1-year and 3-year follow-up]
  • Progression to High-grade Dysplasia or Cancer [Time frame: Up to 3 years]
  • Re-treatment Rate [Time frame: Up to 3 years]
  • Identification of Independent Risk Factors [Time frame: Analysis conducted after all follow-up completed (2029)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Hospital of Lanzhou University — Lanzhou

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. PMID 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. PMID 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. PMID 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. PMID 19171141

Identifiers

NCT: NCT07314554 · LDYYczf2025121801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗