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临床试验/NCT05690412
NCT05690412招募中不适用

Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.

Azienda Unità Sanitaria Locale della Romagna1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Clinical Success

研究概览

简要总结

The aim of our study is to provide data on the efficacy and safety of endoscopic papillectomy, by including consecutive patients treated after 2015, when first guidelines on endoscopic management of ampullary neoplasms were available.

详细描述

Ampullary neoplasm (AN) is a rare disease, but its incidence is increasing. In the last 20 years, endoscopic papillectomy (EP) has become the gold standard treatment for ampullary adenomas and early stage adenocarcinomas, thereby replacing surgical resection, which is burdened by higher rates of morbidity and mortality. However, the data supporting safety and efficacy of EP derive from multiple retrospective studies, that included procedures mostly performed before 2015, when first guidelines on endoscopic management of AN were available. This had an impact on large variability in patient selection criteria and endoscopic techniques, resulting in heterogenous outcomes. Therefore, the aim of our study is to provide data on the efficacy and safety of this technique, by including consecutive patients treated after the standardization of this technique.

All patients who underwent EP at 19 Italian centers between January 2016 and December 2021 were included. Clinical success was defined by the complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period. EP-related adverse events and recurrences were recorded.

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

  • Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen

排除标准

  • Absence of dysplasia on the resected specimen;
  • Locally advanced or metastatic disease (Clinical TNM stage >T1 or N+ or M+);
  • Neoplasm Intra-Ductal Extension (IDE) > 20 mm;
  • Previously treated ampullary neoplasm.

结局指标

主要结局

Clinical Success

时间窗: 2016-2021

Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.

次要结局

  • Adverse Events(2016-2021)
  • Recurrences(2016-2021)
  • Concordance between pre- and post-Endoscopic Papillectomy pathologic findings(2016-2021)

研究者

发起方
Azienda Unità Sanitaria Locale della Romagna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Fabbri

Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals

Azienda Unità Sanitaria Locale della Romagna

研究点 (1)

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