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临床试验/NCT04344847
NCT04344847Unknown不适用

Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

Bassem Mohamed Sieda2 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2016年12月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
338
试验地点
2
主要终点
Excision of GIST during LSG

研究概览

简要总结

LSG is thought to be the best choice for obese patients with conincidental GISTs, as a tumour can be resected along with resecting the stomach within the same procedure. The primary endpoint is that, how much does GIST suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

详细描述

The incidence of unsuspected GIST in LSG specimens in our series was high in comparison to cases reported in the literature.

GISTs could be safely removed laparoscopically during LSG surgery with negative microscopic resection margins, with 1-2cm safety margin. Margins less than 1cm, high mitotic rate are adverse prognostic factors.

Examining the whole stomach before resection is mandatory and can easily be done during LSG, GIST can be removed safely with LSG

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

With institutional review board approval from Zagazig University Hospitals 338. A double-centre prospective study was conducted on prospectively collected data of all morbidly. 17 patients in Zagazig University Hospitals, Faculty of Medicine, Egypt and 321 patients done in bariatric surgery excellence unit in a tertiary hospital in Riyadh-KSA.

入排标准

年龄范围
21 Years 至 42 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All morbid obese patients with BMI more than 35

排除标准

  • previous gastric surgery
  • patients with hiatus hernia
  • age under 21 years

结局指标

主要结局

Excision of GIST during LSG

时间窗: 4 years from start of study

we analyzed the incidence of GISTs in patients underwent LSG and investigated whether simultaneous resection can be oncologically adequate. as long as GIST is distal to staple line with a negative margin, laparoscopic sleeve gastrectomy can be done safely.

次要结局

未报告次要终点

研究者

发起方
Bassem Mohamed Sieda
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Bassem Mohamed Sieda

Assistant professor of general surgery, faculty of medicine

Zagazig University

研究点 (2)

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