Recurrence After Gastric and Intestinal Polyp Resection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLanZhou University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 2 trial groups
Group A: Retrospective Cohort
Group B: Prospective Cohort

Trial outcomes

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

Other outcomes

Sponsors and contacts

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