EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices (EUS)

Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Varices Bleeding
• Intervention / Treatment: Device: Endoscopic ultrasound placement of Coil and glue

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jahangeer Dr Basha, MD DM; Phone Number: 231 04023378888; Email: drjahangeer09@gmail.com
• Study Contact Backup: Name: Sandeep Dr Nath, MD; Phone Number: 121 04023378888; Email: sandip.nath@ymail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology
      • Contact: Jahangeer Dr Basha, MD DM; Phone Number: 04023378888; Email: drjahangeer09@gmail.com
      • Contact: Sandeep Dr Nath, MD; Phone Number: 04023378888; Email: sandip.nath@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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...	Device: Endoscopic ultrasound placement of Coil and glue; The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue; Other Names: Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The outcome will measure number of patient had achieved complete obliteration of varices	Repeat Endoscopic ultrasound findings of residual flow	6 months for observation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient needed re intervention	Repeat coil application on follow-up	6 months for observation
Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)	These are the definite data which will be statistically analyzed	90 days

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Study Director: Mohan Dr Ramchandani, MD DM, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Estimated): August 10, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins
• Other Study ID Numbers: ROSC 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No