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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
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.

 

 
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