| CTRI Number |
CTRI/2024/11/077009 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the efficacy of Splenic Artery Ligation in Liver Transplantation. |
|
Scientific Title of Study
|
Splenic Artery Ligation in Liver Transplantation – A Randomised Controlled Trial (SALT TRIAL) |
| Trial Acronym |
SALT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prithiviraj Nabi |
| Designation |
Associate consultant |
| Affiliation |
Dr.Rela Institute and Medical center |
| Address |
Department of HPB surgery and Liver Transplantation,
Dr.Rela Institute and medical center
7, CLC Works Road, Chrompet
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
704917349 |
| Fax |
|
| Email |
drprithivi.n@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prithiviraj Nabi |
| Designation |
Associate consultant |
| Affiliation |
Dr.Rela Institute and Medical center |
| Address |
Department of HPB surgery and Liver transplantation,
Dr.Rela Institute and Medical center,
7, CLC Works Road, Chrompet
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
704917349 |
| Fax |
|
| Email |
drprithivi.n@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prithiviraj Nabi |
| Designation |
Associate consultant |
| Affiliation |
Dr.Rela Institute and Medical center |
| Address |
Department of HPB surgery and Liver transplantation,
Dr.Rela Institute and Medical center,
7, CLC Works Road, Chrompet
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
704917349 |
| Fax |
|
| Email |
drprithivi.n@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of HPB surgery and Liver transplantation,
Dr.Rela Institute and Medical center,7 CLC works road, Chrompet, Chennai 600044 |
|
|
Primary Sponsor
|
| Name |
Mohamed Rela |
| Address |
Department of HPB surgery and Liver transplantation,
Dr.Rela Institute and Medical center,7 CLC works road, Chrompet, Chennai 600044 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| DrPrithiviraj Nabi |
Dr.Rela Institute and Medical Center |
Department of HPB surgery and Liver transplantation,
Dr.Rela Institute and Medical center,7 CLC works road, Chrompet, Chennai 600044
Chennai
TAMIL NADU |
9540094788
drprithivi.n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Rela Institute and Medical Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No splenic artery ligation |
Patients who fulfill the criteria will not undergo a surgical ligation of Splenic artery after randomisation. |
| Intervention |
Splenic artery ligation |
Patients who fulfill the criteria will undergo a surgical ligation of Splenic artery after randomisation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
-Age more than 18yrs
-Patients undergoing Primary LDLT using a right lobe graft.
|
|
| ExclusionCriteria |
| Details |
-DDLT
-LDLT with left lobe grafts
-LDLT for acute liver failure
-Re-transplant
-Pediatric Liver Transplantation
-Refusal to participate in study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early allograft dysfunction |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| morbidity post operative |
30 day |
| bilirubin |
14 days |
| INR |
14 days |
| Ascites |
14 days |
| Platelets |
14 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="1"
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
Modification(s)
|
1. Objectives of the study : To understand the portal hemodynamics in adult LDLT based on a prespecified portal flow modulation protocol. The primary end point of the study is early allograft dysfunction (EAD) and the secondary end point is time to normalization of bilirubin and INR, rise in platelets, day 14 ascitic output more than 1liter, ICU stay, total hospital stay, morbidity and 90 day mortality. 2. Background and Rationale: Portal inflow modulation (PIM) aimed at reducing portal hyperperfusion is commonly used in in living donor liver transplantation (LDLT) to reduce the risk of small-for- size syndrome (SFSS)/ early allograft dysfunction (EAD) and enhance post operative recovery. There is little consensus on best method of PIM and the impact of portal pressure modulation. Of the different techniques used as PIM, splenic artery ligation (SAL) has the advantage of lesser morbidity compared to splenectomy and hemiportocaval shunt. SAL is used in setting of portal pressure above 15mmHg and/or velocity < 100 cm/sec and /or portal flow < 250ml/min/100g. The portal hemodynamics and impact of SAL is not studied in the group of patients who have portal pressure less than 15 mmHg. This is a randomised control trial to study the impact of SAL on patients undergoing LDLT with portal pressure > 9mmHg and less than 15 mmHg and/or velocity < 100 cm/sec and /or portal flow < 250ml/min/100g. 3. Plan : A single-center, open-label, parallel-arm randomized control trial with and without PIM by splenic artery ligation (SAL) in adult right lobe LDLT. After reperfusion, patients with portal venous pressure (PVP) > 9mmHg and less than 15 mmHg and/or velocity <100 cm/sec and /or portal flow < 250ml/min/100g irrespective of GRWR will be randomized into two groups: PIM and No PIM. |