EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
- Conditions
- Gastric Varices Bleeding
- Interventions
- Device: Endoscopic ultrasound placement of Coil and glue
- Registration Number
- NCT06370169
- Lead Sponsor
- Asian Institute of Gastroenterology, India
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endoscopic ultrasound Placement of coil and glue Endoscopic ultrasound placement of Coil and glue Single arm study The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue Duration 1,3,06 months for observation of gastric varices bleeding...
- Primary Outcome Measures
Name Time Method The outcome will measure number of patient had achieved complete obliteration of varices 6 months for observation Repeat Endoscopic ultrasound findings of residual flow
- Secondary Outcome Measures
Name Time Method Number of patient needed re intervention 6 months for observation Repeat coil application on follow-up
Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days) 90 days These are the definite data which will be statistically analyzed
Trial Locations
- Locations (1)
Asian institute of Gastroenterology
🇮🇳Hyderabad, Telangana, India