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临床试验/NCT07445178
NCT07445178已完成不适用

Piecemeal Resection and Advanced Histology Independently Predict Local Recurrence After Colorectal Snare-based Endoscopic Resection: a Time-to-event Cohort Study

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2025年12月4日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
1
主要终点
Local recurrence of the lesion at the site of the previous resection

研究概览

简要总结

The objective of this retrospective cohort observational study is to identify variables related to the recurrence of colorectal lesions after snare polypectomy resection in colonoscopies. It also aims to evaluate the safety of the procedure. The main questions to be answered are:

  • What endoscopic characteristics are most related to recurrence?
  • What adverse events are related to the procedure?

The researchers will perform a chart analysis looking for demographic, clinical, endoscopic, and histological variables in order to identify which factors are most closely linked to the recurrence of previously resected lesions.

详细描述

  1. Scientific Basis Endoscopic resection represents one of the main strategies for preventing colorectal cancer, significantly reducing the incidence and mortality associated with the disease. Snare polypectomy, with or without the use of thermal energy (cold snare or hot snare), is widely used in clinical practice due to its efficacy, applicability, and favorable safety profile.

However, despite the high initial success rate, local recurrence at the resection site remains a relevant clinical outcome, especially in larger lesions, piecemeal resections, and cases with advanced histological characteristics. The literature shows heterogeneity regarding independent predictors of recurrence, particularly when analyzed using time-to-event methodology.

Given this scenario, it becomes essential to identify clinical, endoscopic, and histopathological variables associated with local recurrence, allowing for better risk stratification and optimization of surveillance protocols. 2. Objectives

Primary Objective:

To identify variables associated with local recurrence after loop colorectal polypectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years at the time of polypectomy;
  • Underwent snare polypectomy, with or without the use of thermal energy (cold snare or hot snare), performed during the study period (2023-2025);
  • Procedure performed at a participating tertiary center, ensuring technical and record standardization;
  • Availability of histopathological examination of the resected lesion, allowing for adequate histological characterization;
  • Performance of at least one documented surveillance colonoscopy, with evaluation of the previous resection site;
  • Adequate recording of clinical and endoscopic variables necessary for analysis (lesion size, location, resection technique, etc.);

排除标准

  • Patients undergoing techniques other than loop polypectomy, such as: Endoscopic submucosal dissection (ESD), advanced mucosal resection not based on conventional loop, primary surgical resection of the lesion;
  • Absence of follow-up colonoscopy, making it impossible to assess the primary outcome (local recurrence);
  • Incomplete clinical, endoscopic, or histopathological data that prevent adequate classification of study variables;
  • Invasive lesions beyond the mucosa (invasive cancer with deep submucosal invasion) that have been referred for immediate surgical treatment without endoscopic follow-up;
  • Loss to follow-up before the first surveillance colonoscopy.

结局指标

主要结局

Local recurrence of the lesion at the site of the previous resection

时间窗: Between the years 2023 and 2025.

Presence of a visible lesion at the scar site of a previous polypectomy, histologically confirmed as adenomatous, serrated, or neoplastic tissue, obtained by biopsy or new resection.

次要结局

  • Presence of metachronous adenoma(Between the years 2023 and 2025.)
  • Adverse events related to the procedure(Between the years 2023 and 2025.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Ribeiro Correa Filho

Medical Doctor

University of Sao Paulo

研究点 (1)

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