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NOT YET RECRUITING
NCT06974344
PHASE4

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

Sponsor: King Faisal Specialist Hospital & Research Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-06-01

Completion Date

2030-09-01

Last Updated

2025-05-15

Healthy Volunteers

No

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.

Locations (1)

Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia