| CTRI Number |
CTRI/2024/05/066720 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of vasoactive drugs on control of variceal bleeding in participants with liver cirrhosis |
|
Scientific Title of Study
|
Comparison of no vasoactive agent with 1-day vasoactive agent after endoscopic variceal ligation in patients with cirrhosis presenting with acute variceal bleeding: an open-label non-inferiority 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 |
AIIMS, New Delhi |
| Address |
Department of Gastroenterology, 3rd floor, Teaching block, AIIMS, Ansari Nagar, South Delhi
Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9968405815 |
| Fax |
|
| Email |
drshalimar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Garg |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Gastroenterology, 3rd floor, Teaching block, AIIMS, Ansari Nagar, South Delhi
Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9810038116 |
| Fax |
|
| Email |
liverclinicaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Govindaraju Chukkala |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Gastroenterology, 3rd floor, Teaching block, AIIMS, Ansari Nagar, South Delhi
Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
8074607807 |
| Fax |
|
| Email |
govind.chukkala@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences, New Delhi, Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar East, New 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 |
AIIMS, New Delhi |
Department of Gastroenterology, Room 3111, 3rd floor, Teaching block, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, 110029
South
DELHI |
9968405815
drshalimar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute Of Medical Sciences, New Delhi |
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 |
| Comparator Agent |
1 day Somatostatin after endoscopic hemostasis |
intravenous Somatostatin infusion @250 microgram/hour will be continued in one group even after endoscopic hemostasis has been achieved. |
| Intervention |
No vasoactive agent after endoscopic hemostasis |
Somatostatin will be stopped in intervention group once endoscopic hemostasis has been achieved. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cirrhosis (Child A,Child B and Child C) with acute esophageal variceal bleeding for whom adequate endotherapy has been performed
2. Age between 18-65 years
3. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients already included in the trial presenting with repeat variceal bleeding
2. Failure to achieve primary hemostasis
3. Bleeding from cardiofundal varices
4. Portosinusoidal vascular disorders, and splanchnic vein thrombosis
5. History of prior TIPS or TIPS thrombosis
6. HVOTO
7. Acute-on-chronic liver failure as per the European Association for the Study of Liver definition
8. Overt Hepatic encephalopathy
9. Patients with any co-existent malignancy including HCC
10. Patients with bleeding diathesis.
11. Pregnant women
12. Patients with renal dysfunction serum creatinine greater than 2 mg per dL
13. Patients with sepsis, shock or requiring mechanical ventilation
14. Contraindications to NSBBs including prior documented hypersensitivity, unacceptable adverse events including hypotension or dizziness and cardiac comorbidities such as heart block
|
|
|
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. Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysis |
1. Cumulative 6-week rebleeding rates after recruitment, assessed using per-protocol and intention-to-treat analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 5-day rebleeding rates with mortality and transplant as competing events
2. 6-week all-cause decompensation, with mortality as additional competing event
3. 6-week transplant-free survival
4. Need for rescue therapy, such as rescue TIPS, Dannis-Ella shunt, Balloon tamponade.
5. Drug-related adverse effects
6. Duration of hospital stay for index bleed
7. Cumulative 6-week rebleeding rates with death and transplant as competing events
8. Cost-effectiveness analysis (see details below)
|
At 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="494"
Sample Size from India="494"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In this study we aim to assess the effect of vasoactive drugs on control of variceal bleeding in patients with liver cirrhosis. Patients will be given all medications as per standard indications for control of bleeding and treatment of liver disease. Patients will have an equal chance of receiving vasoactive agents(somatostatin) for either 1 day or no therapy after endoscopic hemostasis has been achieved. They will be followed up for 6 weeks to look for re bleeding rates, mortality, all cause decompensation. |