To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt

To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt: A Randomized Controlled Trial

Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.

Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.

Study period: 1.0 years

Sample size: 60

This is a pilot RCT, and we decided to enroll 30 patients in each arm.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.; Procedure: Endoscopic Variceal Obturation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Tushar Madke, MD; Phone Number: 01146300000; Email: drtusharmadke@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Tushar Madke, MD; Phone Number: 01146300000; Email: drtusharmadke@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-75 years
2. Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO.

Exclusion Criteria:

1. Non-cirrhotic portal hypertension,
2. History of bleeding from GV
3. Hepatic encephalopathy grade III/IV,
4. Acute kidney injury
5. Patients on beta blocker therapy for > 6 months prior to enrollment in study
6. Hepatocellular carcinoma
7. Portal venous thrombosis
8. Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18
9. Advanced cardiac or pulmonary diseases
10. Pregnancy
11. Patients not giving informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.; Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.	Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.; Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
Active Comparator: Endoscopic Variceal Obturation; endoscopic variceal glue therapy will be done till obturation every 3 weekly.	Procedure: Endoscopic Variceal Obturation; Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patient having bleeding from GV at 12 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving complete or partial obturation of GV	6 months
Proportion of patients having change in grade of EV and bleeding from EV	6 months
Proportion of patients having appearance or worsening of PHG	6 months
Change in HVPG in those patients who bleed after BRTO/PRTO	6 months
Change in HVPG in those patients who bleed after EVO	6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography	6 months
Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography	6 months
Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy	6 months
Proportion of patient developing post procedure liver failure	6 months
Proportion of patient developing post acute kidney injury or sepsis	6 months
Duration of hospital stay poof procedure	12 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 7, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Fibrosis; Esophageal Diseases; Hypertension, Portal; Liver Cirrhosis; Esophageal and Gastric Varices
• Other Study ID Numbers: ILBS-Cirrhosis-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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