Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension

Study Overview
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Brief Summary
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In this study, the investigators aim to prove that performing splenic artery ligation in living donor liver transplantation for patients with portal hypertension is beneficial for early graft function postoperatively. The investigators will be analyzing trend of LFT's (liver function tests) after surgery, time for normalization of bilirubin, INR (international normalised ratio) and decrease in ascites, morbidity, mortality, ICU (intensive care unit) and total hospital stay.

Detailed Description
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Liver transplantation (LT) is the principal treatment for end-stage liver diseases and selected cases of liver neoplasms . Living donor liver transplantation (LDLT) serves as a sole source of liver graft in some countries that do not allow donation from deceased donors for cultural, social, or religious reasons. Hyperperfusion plays an important role in liver regeneration after LDLT, but it may induce injury in the graft . After the reperfusion of a partial graft, there is a significant increase in the portal flow, but Hepatic artery flow remains constant . Excessive portal vein flow may induce injuries in grafts and may contribute to poor graft function. For satisfactory graft function early after LT, the portal vein pressure (PVP) value after reperfusion should be <15 mm Hg. PVP is the most important hemodynamic factor influencing the functional status of the liver and graft regeneration after LT. The use of Splenic Artery Ligation (SAL) as a simple and safe method to modulate portal flow has been reported . The investigators will evaluate that Splenic artery ligation in living donor liver transplantation for patients with Portal hypertension is feasible and efficient technique to improve early graft function and to decrease morbidity and hospital stay and improve outcomes .

Official Title
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Impact of Splenic Artery Ligation in Living Donor Liver Transplantation for Patients With Portal Hypertension on Early Graft Function.

Conditions
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Living Donor Liver Transplantation

Intervention / Treatment
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* Procedure: splenic artery ligation
* Procedure: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol. Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion . Exclusion Criteria: Patients who have Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion. Patients who had splenectomy. Patients who have splenic artery aneurysm.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who undergo Splenic artery ligation<br>If inclusion criteria are met, these group of patients will undergo splenic artery ligation . | Procedure: splenic artery ligation<br>* Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas<br>|
| Active Comparator: No splenic artery ligation<br>If inclusion criteria are met, these group of patients will not undergo splenic artery ligation. | Procedure: No intervention<br>* Splenic artery is not ligated despite the presence of portal hyperperfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early graft dysfunction | Number of patients who develop early graft dysfunction in each group | first postoperative month | 
| Time to normalisation of ascites output | time to normalisation of ascites output (in days) | first postoperative month | 
| Time to normalisation of INR | time to normalisation of INR (in days) | first postoperative month | 
| Time to normalisation of bilirubin | time to normalisation of bilirubin (in days) | first postoperative month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Morbidity as per Clavein Dindo classification | first postoperative month | 
| ICU stay | Duration of ICU stay (in days) | first postoperative month | 
| Mortality | death | first postoperative month | 
| Total hospital stay | duration of total stay in hospital after liver transplantation (in days) | first postoperative month |