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临床试验/NCT06370169
NCT06370169Unknown不适用

Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
The outcome will measure number of patient had achieved complete obliteration of varices

研究概览

简要总结

The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist.

详细描述

In this study Principal investigator recruiting patients with high-risk gastric varices for primary prophylaxis. Gastric varices are dilated submucosal veins in the lining of the stomach, found in patients with portal hypertension or elevated pressure in the portal venous system. The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist. After the procedure patients will be discharged to home unless there is any indication for admission, such as significant abdominal pain, bleeding or chest pain. For enrolment into the study, patient has to sign an informed consent form which is provided at the end. First, we will do baseline evaluation of the patient which includes detailed clinical examination, routine laboratory tests, Upper GI Endoscopy, triphasic CT abdomen. The duration of study is 6 months. Only the routine tests necessary for the management of disease will be charged.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Months 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Each patient must meet all the following criteria to be enrolled in this study:
  • Gastric fundal varices larger than 2.0 cm in total diameter
  • High risk GV (GOV 2/IGV 1)
  • Primary prophylaxis
  • Patients with known fundal varices
  • Ability to give a signed informed consent

排除标准

  • The exclusion criteria for these volunteers will be:
  • Patients with a history of TIPS or any other portosystemic shunt procedure
  • Oesophageal stricture
  • Patient not fit for general anaesthesia
  • Secondary prophylaxis
  • Pediatric Patients (<18 years)
  • Pregnant or lactating mother
  • Not willing to participate

结局指标

主要结局

The outcome will measure number of patient had achieved complete obliteration of varices

时间窗: 6 months for observation

Repeat Endoscopic ultrasound findings of residual flow

次要结局

  • Number of patient needed re intervention(6 months for observation)
  • Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)(90 days)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

clinical professor

Asian Institute of Gastroenterology, India

研究点 (2)

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