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CTRI Number  CTRI/2024/06/069507 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Role of incompletely blocking one of the splenic artery branches in patients with chronic liver disease patients having low blood cell counts presenting with blood in vomiting and to observe the outcomes in them 
Scientific Title of Study   Role of partial splenic embolization combined with endoscopic therapies in cirrhotic patients with hypersplenism having variceal bleed: An observational 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  Dhira Shobith Munipati 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Surgery, Old block, 2nd floor, Jawaharlal Institute of Post graduate Medical research and Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9177493359  
Fax    
Email  shobzi20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vishnu Prasad N R 
Designation  Professor and Head of Department of Surgery 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Surgery, Old block, 2nd floor, Jawaharlal Institute of Postgraduate Medical Education and Research

Pondicherry
PONDICHERRY
605006
India 
Phone  9442233487  
Fax    
Email  vishnupnr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dhira Shobith Munipati 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Surgery, Old Block, 2nd floor, beside Amrit pharmacy

Pondicherry
PONDICHERRY
605006
India 
Phone  9177493359  
Fax    
Email  shobzi20@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, Dhanvantari Nagar, 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu,Dhanvantari nagar, Puducherry, 605006 
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 
Dhira Shobith Munipati  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Surgery,2nd floor Old block, next to Amrit Pharmacy
Pondicherry
PONDICHERRY 
9177493359

shobzi20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Cirrhotic patients having variceal bleed and portal hypertension with hypersplenism and thrombocytopenia in Group-1
Cirrhotic patients having variceal bleed and portal hypertension without hypersplenism and thrombocytopenia in Group-2 
 
ExclusionCriteria 
Details  Patients less than 18 years of age and more than 75 years of age
Previous therapy (splenectomy, PSE, tissue adhesive injection) to prevent rebleeding
Bleeding from isolated gastric or ectopic varices
Hepatocellular carcinoma or other malignant tumours
Hepatic failure, and Child–Pugh class C with large amount ascites, or grade 3–5 hepatic encephalopathy, or severe coagulopathy
Contraindications for PSE
Pregnancy and lactation 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1)To study the recurrence and variceal rebleeding rate in cirrhotic patients with hypersplenism undergoing Partial splenic embolization combined with endoscopic therapies

2)To study the recurrence and variceal rebleeding rate in cirrhotic patients undergoing endoscopic management alone.
 
2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the incidence of complications in cirrhosis patients with hypersplenism undergoing Partial splenic embolization combined with endoscopic variceal ligation.  2 years 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/08/2024 
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)   Not Applicable 
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  

This is an observational study. The study will be carried out at the Surgery Department of JIPMER after obtaining Institute’s Ethical committee approval. All patients will be informed about the study and written informed consent will be taken before participation. The patients qualifying the inclusion and exclusion criteria for this study will be recruited for the study. Liver cirrhosis will be diagnosed by an ultrasound evaluation. Baseline blood investigations including haemoglobin, total leukocyte count, platelet count, renal and liver functions will be done. After stabilizing the hemodynamics, the patients will undergo endoscopic examination and endoscopic treatment in the department of Surgery, JIPMER.EVL will be carried out for oesophageal varices at 1 cm above the Z-line in a spirally ascending fashion. After the initial session, EVL will be performed at regular intervals of about 2 weeks till eradication of varices. Eradication of the varices will be defined as no visible varices in endoscopy or the presence of only fibrosed varices not requiring ligation. Partial Splenic Embolization will be performed 1 week after the endoscopic treatment in patients with hypersplenism and thrombocytopenia. These patients will undergo contrast enhanced computed tomography (CECT) scanning to observe the basal status of the spleen. Splenic arteriography will be performed on a digital subtraction angiography (DSA) system via the femoral artery access. Progressive embolization of splenic artery will be performed as the standard of care by repeated injections of a gelatin sponge under the DSA control until a 60–80% reduction in the splenic blood flow is achieved. Broad-spectrum antibiotic prophylaxis will be administered in the peri-intervention period. A post-interventional enhanced CT scan will be  performed to confirm the embolization area 2–3 weeks after the PSE. Patients without hypersplenism (group 2) will undergo endoscopic management alone. A standard dose of NSBB (propranolol) will be given to all patients if there were no contraindications. The primary endpoint of the study will be variceal rebleeding and the secondary endpoints will be severe variceal recurrence and mortality during the 3 month follow-up. In the follow up period blood investigations including haemoglobin, total leukocyte count, platelet count, renal and liver functions will be will be 

 
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