| CTRI Number |
CTRI/2024/09/074042 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to compare the effect of radiologic versus endoscopic or drug therapy for the prevention of the first episode of bleeding from gastric varices in patients with liver cirrhosis |
|
Scientific Title of Study
|
Comparison of retrograde transvenous obliteration, endoscopic ultrasound-guided coil and glue embolization and beta blockers for primary prophylaxis of high-risk fundal varices in patients with liver cirrhosis: a Multi Centre open-label randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalimar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology, All India Institute of Medical Sciences
Ansari Nagar
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarthak Saxena |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenetrology
All India Institute of Medical Sciences
South
DELHI
110029
India |
| Phone |
9953538070 |
| Fax |
|
| Email |
apeejaysarthak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarthak Saxena |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenetrology
All India Institute of Medical Sciences
South
DELHI
110029
India |
| Phone |
9953538070 |
| Fax |
|
| Email |
apeejaysarthak@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalimar |
All India Institute of Medical Sciences, Delhi |
Room 127, Human nutrition unit , Old OT block , Department of gastroenterology, All India Institute of Medical Sciences, Delhi
South
DELHI |
9868397211
drshalimar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee for post graduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
balloon occluded retrograde transvenous obliteration |
Patients will undergo BRTO within one week of randomization and will be followed up prospectively for 2 year. Obliteration will be done using a sclerosant sodium tetradecyl sulphate (STS). Volume of STS required will be determined during the time of procedure based on Balloon occluded retrograde transvenous venogram (BRT-V) . |
| Intervention |
endoscopic ultrasound-guided coil embolization |
Patients will undergo EUS-CCI within one week of randomization and will be followed up prospectively for 2 year. Number and size of coils and volume of glue injected will be determined based on size of gastric varix on EUS. |
| Comparator Agent |
Standard Medical Therapy (SMT) with beta blockers |
Patients will be started on beta blockers as outpatients, which will be titrated as per current guidelines and will be prospectively followed up for 2 year. Starting dose 6.25 mg in two divided doses with uptitration every 3 days to maximum dose of 12.5mg per day based on heart rate more than 60/min and SBP more than 90mmg of Hg |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with liver cirrhosis with high-risk fundal varices (GOV-2/IGV-1) which has never bled.
2. Age between 18-70 years
3. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with a prior history of bleeding from fundal varices
2. Porto sinusoidal vascular disease
3. Hepatocellular carcinoma ( beyond Milan criteria) or any other coexistent malignancy
4. Portal vein thrombosis or portal cavernoma
5. Contraindications to BRTO (provided in the table below) or prior BRTO
6. Active sepsis with or without septic shock
7. Underlying cardiopulmonary disease
8. Acute-on-Chronic liver failure as per EASL definition
9. Chronic Kidney Disease or Acute Kidney Injury with serum creatinine greater less 1.5 mg/dl
10. Pregnant women
11. Denied consent for participation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the differences in the gastric varix hemorrhage rates at 1-year between the 3 arms |
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the differences in all-cause and gastric varix bleeding-related mortality between the 3 arms at 12 and 24 months from randomization.
2. To evaluate the change in liver function (assessed by Model for end stage liver disease score) at 12 and 24 months from randomization between the 3 arms.
3. To assess the differences in complications- ascites/hepatic encephalopathy/esophageal variceal hemorrhage at 1, 3, 6,12 and 24 months between the 3 arms.
4. To assess the cost assessment between the three groups. |
1. 12 and 24 months
2. 12 and 24 months
3. 24 months |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gastric varices (GV) develop in 20% of patients with liver cirrhosis. They are commonly classified based on their anatomical location as per Sarin’s classification into gastroesophageal and isolated gastric varices. As a group, bleeding from gastric varices occurs less frequently than esophageal varices (EV). Every episode of variceal hemorrhage from GV is associated with greater blood loss, higher transfusion requirements and greater mortality as compared to acute variceal bleeding (AVB) from EV. All subtypes of gastric varices do not behave similarly clinically. Gastroesophageal varix type 1 (GOV-1) is the most common subtype of gastric varices identified clinically but is associated with very low rates of bleeding compared to gastroesophageal varices type 2 (GOV-2) and isolated gastric varices type 1 (IGV-1). GOV-2 and IGV-1 have the highest rates of bleeding and are collectively called fundal varices due to their location in the fundus of the stomach. Available literature in GV focuses on the prevention of rebleeding (secondary prophylaxis) after an index AVB, with limited data available on primary prophylaxis of fundal varices. We propose in this randomized
controlled trial to compare the efficacy of endoscopic ultrasound-guided coil
embolization with balloon occluded retrograde transvenous obliteration or
beta-blockers alone in preventing a first episode of variceal hemorrhage
(primary prophylaxis) in patients with liver cirrhosis having fundal varices.
|