| CTRI Number |
CTRI/2025/01/079297 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic Procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Emergent vs Early Endoscopy (type of endoscopy procedure) in Cirrhotic Patients With Acute Variceal Bleed (Disease). |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C Cirrhotic Patients With Acute Variceal Bleed (AVB)-EARLY - AVB |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanda Kavitha |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West DELHI 110070 India |
| Phone |
01146300000 |
| Fax |
|
| Email |
sandakavitha1001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harsh Vardhan Tevethia |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West DELHI 110070 India |
| Phone |
01146300000 |
| Fax |
|
| Email |
harshvardhantevethia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Harsh Vardhan Tevethia |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
DELHI 110070 India |
| Phone |
01146300000 |
| Fax |
|
| Email |
harshvardhantevethia@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj,New Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj,New Delhi-110070. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanda Kavitha |
Institute of Liver and Biliary Sciences |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070. South West DELHI |
01146300000
sandakavitha1001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Early endoscopy-
UGIE T4-T12 hrs |
After Entering to emergency based on time of hemetemsis and based on presentation to ER , patient will be assessed and based on hemodyamic stability patient can be taken Early/Emergent endoscopy.
DURATION: 4 to 12 hours
Frequency: once |
| Intervention |
Emergent Endoscopy
UGIE T1-T4 hrs |
After Entering to emergency based on time of hemetemsis and based on presentation to ER , patient will be assessed and based on hemodyamic stability patient can be taken Early/Emergent endoscopy.
DURATION: 1 to 4 hours
Frequency: once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Child B and C cirrhotic patients with history of AVB.
2. Fluid responsive within 1 hour after resuscitation |
|
| ExclusionCriteria |
| Details |
1. EHPVO / NCPH
2.Lack of consent Pregnancy
3. Child A cirrhotics
4. Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
5. Need of Dual vasopressors at presentation In Hospital patients with Bleed
6. HCC patients with AVB
7. Patients presented with AVB on going antiplatelets/anticoagulants. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of mortality within 6 weeks in Child B&C |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of rebleed within 6 weeks in Chid B &C. |
6 weeks |
| Proportion of patients rebleed at D5. |
Day 5 |
| Proportion of patients required repeated hospital admissions and number days pf hospitalisation |
6 weeks |
| Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy. |
6 weeks |
| Proportion of patients developing Ischemic hepatitis. |
6 weeks |
| Patients need of TIPS/BRTO/EUS in AVB. |
6 weeks |
| Percentage of endoscopic hemostasis is achieved at 24 hours. |
24 hours |
| Percentage requiring ICU saty and duration of saty post AVB |
6 weeks
|
|
|
Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Summary-Variceal bleeding - 70% of all upper
gastro-intestinal bleeding episodes in patients with portal hypertension, and
they result from esophageal varices (EVs), gastric varices (GVs), or ectopic
varices.
Management of Acute variceal bleeding includes endoscopic
variceal ligation (EVL) along with vasoactive agents. Inspite of successful
hemostasis, this is associated with high variceal rebleeding (VRB) in Child B
and C cirrhosis and have higher 6-week mortality rates and liver related
adverse events. From time of presentation to emergent endoscopy that is 4 hours
can reduce the mortality when compared early endoscopy within 4-12 hours so
that mortality rate related to bleed can reduced and early hemostasis can be
achieved.
Aim and Objectives -To assess the role of Emergent Endoscopy
vs Early endoscopy in patients with Acute variceal bleed in CHILD B&C
Cirrhosis.
Hypothesis - Early use of endoscopy along with adequate
resuscitation and medical optimization in patients with Child B/C cirrhosis
would lead to higher rates of endoscopic hemostasis thereby associated with
better clinical outcomes, in terms of in hospital mortality rate and Liver
failure related mortality in post bleed, recurrent bleeding rates.
Study population- Patient presenting with AVB as per
definition in Child B &C cirrhotics.
Study design- Randomized Control Trial Non Inferior Trial.
Study area- ILBS , Delhi Intervention: Patient after screening for all
exclusion criteria will be randomized into either Emergent endoscopy or Early
endoscopy
Monitoring and assessment: All patients would undergo vital
and baseline parameter screening before randomization. Based on randomization
they will undergo the Endoscopy procedure.Post procedure patient will be
followed and evaluated for rebleed, mortality, liver related events if any like
Hepatic encephalopathy, Ascites, Ischemic hepatitis.
|