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临床试验/NCT03031704
NCT03031704Unknown不适用

French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年1月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Number of recurrence after surgery

研究概览

简要总结

Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.

All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.

Hundred and twenty patients will be included and followed 2 years after mucosectomy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy

排除标准

  • patients with previous endoscopic resection,
  • patients prsenting lesion involving the major papilla, sub mucosal lesions
  • patient with familial adenomatous polyposis
  • patient undergoing use of antiplatelet agent during the five last days

结局指标

主要结局

Number of recurrence after surgery

时间窗: 2 yeras

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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