Recurrence Rate and Risk Factors After Endoscopic Resection of Gastric and Intestinal Polyps: A Retrospective and Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Short-term Recurrence Rate at 1 Year
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Short-term Recurrence Rate at 1 Year
时间窗: 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).
Long-term Recurrence Rate at 3 Years
时间窗: 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.
Cumulative Recurrence Rate
时间窗: Up to 3 years post-resection
Overall recurrence rate combining 1-year and 3-year surveillance results
次要结局
- Characteristics of Recurrent Polyps(At 1-year and 3-year follow-up)
- Identification of Independent Risk Factors(Analysis conducted after all follow-up completed (2029))
- Recurrence-free Survival Time(Up to 3 years)
- Progression to High-grade Dysplasia or Cancer(Up to 3 years)
- Re-treatment Rate(Up to 3 years)
研究者
Zhaofeng Chen
Clinical Professor
LanZhou University