Splenic Artery Ligation in Liver Transplantation – A Randomised Controlled Trial (SALT TRIAL)

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.