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NCT Number: NCT07314554

Recurrence After Gastric and Intestinal Polyp Resection

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.

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Key information

Conditions

Gastric Polyps Adenoma Adenomatous Polyps Colon Polyps Colonic Polyps Colorectal Adenoma Colorectal Polyps Digestive System Diseases Digestive System Neoplasms Gastric Adenoma and Early Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyposis, Gastric Polyps Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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. Cumulative Recurrence Rate

    Time frame: Up to 3 years post-resection

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

Secondary outcomes

  1. Recurrence-free Survival Time

    Time frame: Up to 3 years

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

  2. 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.

  3. 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.

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Qiangqiang Tian

CONTACT

[email protected]

86+15009460497

Sponsors and collaborators

Lead sponsor

LanZhou University

Other

Registry information

Official study title

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

Acronym: RAGIP

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 2, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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