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临床试验/NCT05258604
NCT05258604Unknown不适用

Endoscopic Band Ligation Versus Argon Plasma Coagulation in Management of Gastric Antral Vascular Ectasia; Randomized Clinical Trial

Assiut University0 个研究点目标入组 48 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
主要终点
prevalence of gastric antral vascular ectasia (GAVE) among other causes of gastrointestinal bleeding and study different endoscopic modalities in GAVE management according to its side effects and capacity in management of GAVE

研究概览

简要总结

  • overall aim: To compare the efficacy and safety of endoscopic band ligation and endoscopic argon plasma coagulation for the management of gastric antral vascular ectasia.
  • Secondary aims:
  1. Study risk factors of GAVE.
  2. Prevalence of GAVE among causes of non-variceal gastrointestinal bleeding.

详细描述

Gastric antral vascular ectasia (GAVE) is a capillary-type vascular malformation characterized endoscopically by red, angiomatous lesions originating in the antrum and organized either in stripes or in a diffuse pattern.

GAVE may cause chronic iron-deficiency anemia with or without the presence of overt gastrointestinal bleeding, manifested commonly by melena, may account for about 4% of the causes of non-variceal bleeding.

GAVE can be isolated or associated with systemic conditions, especially in patients with liver cirrhosis, scleroderma, chronic renal failure, and after bone marrow transplantation.

Multiple mechanisms have been proposed as the origin of its development. These have included gastric dysmotility leading to chronic mucosal trauma and subsequent fibromuscular hyperplasia and vascular ectasia or an autoimmune reaction to gastric blood vessels among the main contributing factors.

Management of GAVE-related gastrointestinal bleeding is a clinically challenging issue. In the last two decades, many therapeutic options and modalities have been applied for GAVE including medical, endoscopic, and surgical management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Both sexes will be included.
  • Age above 18 years old patients will be included.
  • With overt or occult bleeding from GAVE.
  • Characteristic endoscopic findings of GAVE: GAVE was limited to the antrum and its appearance either watermelon stomach or diffuse pattern.

排除标准

  • • All causes of emergence upper GIT bleeding other than GAVE.
  • Patient with contraindication to general anesthesia

结局指标

主要结局

prevalence of gastric antral vascular ectasia (GAVE) among other causes of gastrointestinal bleeding and study different endoscopic modalities in GAVE management according to its side effects and capacity in management of GAVE

时间窗: two years

prevalence OF GAVE will be assessed according to number of cases presented by gastrointestinal bleeding diagnosed as GAVE by upper endoscopy side effects of endoscopic modalities will be assessed according 1. incidence of re-bleeding 2. Need for blood transfusion according to numbers of packed red blood cells units. 3. Hospital stay and total cost. 4. post procedure gastric ulceration detected by upper endoscopy.

次要结局

未报告次要终点

研究者

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

Esraa Yousef Mohammed

Assistant Lecturer

Assiut University

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