EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: Gastric Varices Bleeding

Treatments: Device: Endoscopic ultrasound placement of Coil and glue

Study type: Interventional

Funder types: Other

Identifiers

NCT06370169

ROSC 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 months to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: -

Each patient must meet all the following criteria to be enrolled in this study:

1. Gastric fundal varices larger than 2.0 cm in total diameter
2. High risk GV (GOV 2/IGV 1)
3. Primary prophylaxis
4. Patients with known fundal varices
5. Ability to give a signed informed consent

Exclusion criteria: -

The exclusion criteria for these volunteers will be:

1. Patients with a history of TIPS or any other portosystemic shunt procedure
2. Oesophageal stricture
3. Patient not fit for general anaesthesia
4. Secondary prophylaxis
5. Pediatric Patients (<18 years)
6. Pregnant or lactating mother
7. Not willing to participate

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Endoscopic ultrasound Placement of coil and glue

Other group

Description:

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...

Treatment:

Device: Endoscopic ultrasound placement of Coil and glue