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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

Primary Purpose

Liver Cirrhosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Balloon occluded/plug assisted retrograde transvenous obliteration.
Endoscopic Variceal Obturation
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 years 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: Non-cirrhotic portal hypertension, History of bleeding from GV Hepatic encephalopathy grade III/IV, Acute kidney injury Patients on beta blocker therapy for > 6 months prior to enrollment in study Hepatocellular carcinoma Portal venous thrombosis Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18 Advanced cardiac or pulmonary diseases Pregnancy Patients not giving informed consent

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.

Endoscopic Variceal Obturation

Arm Description

Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.

endoscopic variceal glue therapy will be done till obturation every 3 weekly.

Outcomes

Primary Outcome Measures

Proportion of patient having bleeding from GV at 12 months

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2023
Last Updated
January 7, 2023
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05677230
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.
Arm Type
Experimental
Arm Description
Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
Arm Title
Endoscopic Variceal Obturation
Arm Type
Active Comparator
Arm Description
endoscopic variceal glue therapy will be done till obturation every 3 weekly.
Intervention Type
Procedure
Intervention Name(s)
Balloon occluded/plug assisted retrograde transvenous obliteration.
Intervention Description
Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Variceal Obturation
Intervention Description
Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly.
Primary Outcome Measure Information:
Title
Proportion of patient having bleeding from GV at 12 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients achieving complete or partial obturation of GV
Time Frame
6 months
Title
Proportion of patients having change in grade of EV and bleeding from EV
Time Frame
6 months
Title
Proportion of patients having appearance or worsening of PHG
Time Frame
6 months
Title
Change in HVPG in those patients who bleed after BRTO/PRTO
Time Frame
6 months
Title
Change in HVPG in those patients who bleed after EVO
Time Frame
6 months
Title
Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography
Time Frame
6 months
Title
Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography
Time Frame
6 months
Title
Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy
Time Frame
6 months
Title
Proportion of patient developing post procedure liver failure
Time Frame
6 months
Title
Proportion of patient developing post acute kidney injury or sepsis
Time Frame
6 months
Title
Duration of hospital stay poof procedure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years 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: Non-cirrhotic portal hypertension, History of bleeding from GV Hepatic encephalopathy grade III/IV, Acute kidney injury Patients on beta blocker therapy for > 6 months prior to enrollment in study Hepatocellular carcinoma Portal venous thrombosis Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18 Advanced cardiac or pulmonary diseases Pregnancy Patients not giving informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Tushar Madke, MD
Phone
01146300000
Email
drtusharmadke@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Tushar Madke, MD
Phone
01146300000
Email
drtusharmadke@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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