Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide.

The goal of this clinical trial is to compare two treatments for regulating blood flow in small liver grafts during living donor liver transplantation (LDLT).

It had two arms (groups): Octreotide Infusion Arm (active comparator) and Splenic Artery Ligation (SAL) Arm (active comparator).

Intraoperative ligation of the splenic artery using non-absorbable suture near its origin.

The registry classes the interventions as drug and procedure.

More on the Plan

Small grafts are prone to injury from high venous portal and low hepatic artery flow, leading to small-for-size syndrome (SFSS), a major cause of transplant failure.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 and \<70 years. Male and female genders. Undergoing Living Donor Liver Transplant (LDLT). Receiving a small-for-size graft requiring portal flow modulation. Informed consent provided.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: deceased donor liver transplantation (ddlt); dual ldlt or dual ldlt/ddlt; known allergy to octreotide / somatostatin analogue.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2025-06-01 with completion listed for 2030-05-01.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Median Comprehensive Complication Index® (CCI®) (time frame: From the day of liver transplantation (Day 0) through postoperative day 90). Small-for-size syndrome (SFSS) rate (time frame: From the day of liver transplantation (Day 0) through postoperative day 14). Number and proportion of postoperative complication types and grades within 90 days (time frame: From the day of liver transplantation (Day 0) through postoperative day 90).

It also tracked 8 secondary outcomes, for example Median portal venous flow (PVF) rate on intraoperative Liver Doppler ultrasound, Median Hepatic artery resistive index (RI) on intraoperative Liver Doppler ultrasound, Hepatic artery diastolic flow rate, Median intensive care unit length of stay in days, Graft survival rate at 1-year post-transplantation and Patient survival rate at 1-year post-transplantation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 80 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.