NCT06974344

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

Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial (SCALOP-RCT) investigates two strategies for managing portal hyperperfusion in adults receiving small living donor liver transplants (graft-to-recipient weight ratio \<0.80%). 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. Interventions Compared * Octreotide: A somatostatic analogue that reduces portal venous flow and increased hepatic artery flow to the liver by constricting blood vessels, given continuously through an IV during and after surgery. * Splenic Artery Ligation (SAL): A surgical procedure that ties off the artery supplying the spleen, indirectly lowering portal venous flow. Study Design * Randomization: Participants are assigned 1:1 to octreotide or SAL during transplant surgery. * Rescue Protocol: If portal venous flow remains too high after the initial treatment, patients may switch to the alternative therapy (crossover). * Blinding: Surgeons know the treatment, but outcome assessors and data analysts do not. Key Assessments * Primary: Total complication burden at 90 days (Comprehensive Complication Index(R) (CCI(R)). * Secondary: Blood flow measurements, early liver function, hospital stay, survival, and quality of life. * Rationale: Current approaches vary widely, with no consensus on whether medications or surgery work better. This trial will provide evidence to standardize care, potentially improving graft survival and expanding donor options. * Population: 80 adults (18-70 years) undergoing LDLT at a single tertiary center. * Innovation: First head-to-head comparison of these strategies with rigorous hemodynamic monitoring and crossover rescue design.

Conditions

• Small-for-Size Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-05-01
• Completion: 2030-09-01
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: Saudi Arabia