Clinical trial NCT06370169: EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
Official title: Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Varices Bleeding
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: The outcome will measure number of patient had achieved complete obliteration of varices
timeFrame: 6 months for observation
Secondary outcomes:
measure: Number of patient needed re intervention
timeFrame: 6 months for observation
measure: Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)
timeFrame: 90 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian institute of Gastroenterology
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Mohan Dr Ramchandani, MD DM
role: STUDY_DIRECTOR
References: