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Набор скоро начнётся NCT07314554

Recurrence After Gastric and Intestinal Polyp Resection

Наблюдательное Gastric Polyps Intestinal Polyps Colon Polyps Colorectal Polyps

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Gastric Polyps, Intestinal Polyps, Colon Polyps, Colorectal Polyps. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Первичные конечные точки

  • Short-term Recurrence Rate at 1 Year [Срок оценки: 1 year post-resection (10-14 months acceptable)]
  • Long-term Recurrence Rate at 3 Years [Срок оценки: 3 years post-resection (33-39 months acceptable)]
  • Cumulative Recurrence Rate [Срок оценки: Up to 3 years post-resection]
Вторичные конечные точки (5)
  • Recurrence-free Survival Time [Срок оценки: Up to 3 years]
  • Characteristics of Recurrent Polyps [Срок оценки: At 1-year and 3-year follow-up]
  • Progression to High-grade Dysplasia or Cancer [Срок оценки: Up to 3 years]
  • Re-treatment Rate [Срок оценки: Up to 3 years]
  • Identification of Independent Risk Factors [Срок оценки: Analysis conducted after all follow-up completed (2029)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The First Hospital of Lanzhou University — Lanzhou

Публикации

  • 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

Идентификаторы

NCT: NCT07314554 · LDYYczf2025121801

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗