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

Summary

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). The main questions it aims to answer are:

* Is octreotide (a medication) as effective or better than splenic artery ligation (surgery) in reducing complications after transplantation?
* Which treatment better controls blood flow while causing fewer side effects?

Researchers will compare octreotide (given through an IV) to splenic artery ligation (performed during surgery) to see which approach works best for patients receiving small liver grafts.

Participants will:

* Be randomly assigned to receive either octreotide or splenic artery ligation during their transplant surgery
* Have their liver blood flow monitored closely during and after surgery

Be followed for 90 days and 1 year to track complications, hospital stay, recovery, and survival.

This study may help doctors choose safer, more effective treatments for patients needing small liver grafts.

Conditions

• Small-for-Size Syndrome

Interventions

DRUG

Octreotide (drug)

Continuous intravenous octreotide acetate infusion initiated at hepatic reperfusion during living donor liver transplantation (LDLT). The initial dose is 1 mcg/kg/hr, titrated intraoperatively based on portal venous flow (PVF) and hepatic artery flow / resistive index (RI) measurements. The infusion continues postoperatively in the ICU until stable graft hemodynamics are achieved (target PVF \<5 mL/min/g and presence of diastolic hepatic arterial flow). Dose adjustments are permitted for efficacy or safety concerns, with all modifications documented. The intervention is administered via central venous access using standard infusion protocols

PROCEDURE

Splenic Artery Ligation (SAL)

Intraoperative ligation of the splenic artery performed during living donor liver transplantation (LDLT) using non-absorbable suture material (e.g., polypropylene). The ligation is typically placed near the splenic artery origin for maximal portal flow modulation, with exact positioning determined by surgeon assessment of vascular anatomy and intraoperative hemodynamics (targeting portal venous flow \<5 mL/min/g). The procedure is performed under direct visualization during the transplant operation, with post-ligation Doppler ultrasound confirmation of hemodynamic response within 60 minutes of biliary anastomosis.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center

  lead OTHER

Principal Investigators

• Dieter C. Broering, MD, PhD · Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

• Dimitri A. Raptis, MD, MSc, PhD · Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

• Massimo Malago, MD, PhD · Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2030-05-01

Completion

2030-09-01

Countries

• Saudi Arabia

Study Locations