NCT06370169

EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Months – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Varices Bleeding

Interventions

Type	Name	Description
DEVICE	Endoscopic ultrasound placement of Coil and glue	The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-03-30
• Completion: 2024-08-10
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: India