FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060491 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Endoscopic Ultrasound (EUS) guided management of gastric varices: coil embolisation with absorbable gelatin sponge versus coil embolisation with cyanoacrylate glue injection 
Scientific Title of Study   Efficacy and safety of endoscopic ultrasound guided coil embolisation with absorbable gelatin sponge versus coil embolisation with cyanoacrylate glue injection for management of gastric varices: A randomized comparative study 
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 Ashok Jhajharia 
Designation  Associate Professor 
Affiliation  SMS MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor SMS Superspeciality Hospital, Jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Jhajharia 
Designation  Associate Professor 
Affiliation  SMS MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor SMS Superspeciality Hospital, Jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9414236572  
Fax    
Email  drashokjhajharia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Namit Gupta 
Designation  Senior Resident 
Affiliation  SMS Medical College Jaipur 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor, SMS Superspeciality Hospital, Jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9815018552  
Fax    
Email  guptanamit116@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College & Hospital Jaipur 
 
Primary Sponsor  
Name  MMCSBY Scheme Govt of Rajasthan 
Address  Department of Gastroenterology Room No. 313, IIIrd Floor, SMS Superspeciality Hospital, Jaipur 
Type of Sponsor  Government medical college 
 
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 Ashok Jhajharia  SMS Medical College Jaipur  Department of Gastroenterology, Room No. 313, IIIrd Floor, SMS Superspeciality Hospital, Jaipur Jaipur RAJASTHAN Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 9414236572

drashokjhajharia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
office of ethics committee sms medical college jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coil plus cyanoacrylate glue   Patients will be randomly allocated in a 1:1 manner to either EUS-guided coil embolization with absorbable gelatin sponge OR EUS guided coil embolization with cyanoacrylate glue injection for the management of gastric varices types GOV II and IGV I. A total of 35 patients with gastric varices will be enrolled & managed with EUS guided coil embolization with cyanoacrylate glue, over a period of one year of study duration.  
Intervention  Coil plus sponge gelform  Patients will be randomly allocated in a 1:1 manner to either EUS-guided coil embolization with absorbable gelatin sponge OR EUS guided coil embolization with cyanoacrylate glue injection for the management of gastric varices types GOV II and IGV I. A total of 35 patients with gastric varices who will be enrolled & managed with EUS guided coil embolization with sponge gelfoam, over a period of one year of study duration.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patient with age ≥ 18 years
2. Diagnosed with gastric varices type GOV2 or IGV1 on upper GI endoscopy according to the sarin classification.
3. All patients will be included irrespective of bleeding status (past bleeder/ non bleeder / active bleeder).
 
 
ExclusionCriteria 
Details  1. Age < 18 years and > 75 year of age
2. Platelet count < 50 000 /dl or an international normalized ratio (INR) ≥ 2
3. Patient with concurrent hepatorenal syndrome and/or multiorgan failure
4. Pregnant or nursing female
5. Patient with prior surgery of upper gastrointestinal tract
6. Hemodyanimically unstable/ Shock (bp < 90 mm Hg)
7. EUS specific procedural contraindication
8. Patients who did not give consent
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of cases with obliteration of varices evaluated via EUS doppler
2. Proportion of cases with reappearance of varices
3. Proportion of cases with rebleeding
4. Proportion of cases with need for reintervention
5. Proportion of cases needs blood transfusion
6. Proportion of cases with pre and post treatment hemoglobin values.
7. Proportion of cases with adverse events
8. Proportion of cases with technical success
 		 Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure.
The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated.
Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of cases needs blood transfusion
2. Proportion of cases with pre and post treatment hemoglobin values.
3. Proportion of cases with adverse events
4. Proportion of cases with technical success
 		 Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure.
The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated.
Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   25/12/2023 
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)
Modification(s)  		 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  

Gastric varices are important cause of hemetemesis in patients of portal hypertension either in cirrhotic or non cirrhotics and it needs urgent effective and safe treatment modalities to prevent morbidity and mortality

The purpose of this study is to statistically compare the efficacy and safety of newer endoscopic ultrasound guided coil embolization with gelatin sponge and coil embolization with cyanoacryalte glue injection in management of gastrc varices. 
Close