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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

May 1, 2030

Study Completion Date

September 1, 2030

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.

Trial Locations (1)

12713

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

All Listed Sponsors
lead

King Faisal Specialist Hospital & Research Center

OTHER