| 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
|
|
|
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
|
|
|
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 |