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.
Age ≥ 18 and <70 years
Male and female genders
Undergoing Living Donor Liver Transplant (LDLT)
All indications
Deceased Donor Liver Transplantation (DDLT)
Dual LDLT or dual LDLT/DDLT
Pregnancy
Known allergy to Octreotide / Somatostatin analogue
Parallel
Octreotide (drug)
DrugContinuous 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
Splenic Artery Ligation (SAL)
Procedure/SurgeryIntraoperative 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.
Median Comprehensive Complication Index® (CCI®)
The Comprehensive Complication Index® (CCI®) is a validated, quantitative metric that reflects the cumulative burden of postoperative complications by integrating all complications experienced by a patient into a single continuous scale (range: 0 (no complications) to 100 (death)). The CCI® is calculated using the Clavien-Dindo Classification to grade the severity of each complication (Grades I-V), with weights assigned based on clinical impact.
Small-for-size syndrome (SFSS) rate
SFSS is a clinically defined syndrome occurring in recipients of small-for-size liver grafts (graft-to-recipient weight ratio (GRWR) \<0.80%), characterized by: * Persistent cholestasis (serum total bilirubin \>5.8 mg/dL beyond postoperative day 14) * Refractory ascites (daily ascitic fluid output \>1 L despite diuretics beyond day 14) * Coagulopathy (INR \>2 with hypoalbuminemia \<2.5 g/dL beyond day 14) Diagnostic Criteria * Requires ≥2 of the above features (per ILTS-iLDLT-LTSI 2023 Consensus Guidelines). * Excludes other causes of graft dysfunction (e.g., hepatic artery thrombosis, acute rejection).
Number and proportion of postoperative complication types and grades within 90 days
All complications occurring within 90 days post-transplantation will be prospectively recorded and graded using the Clavien-Dindo Classification, a validated system for surgical morbidity. * Grade I: Minor deviations (e.g., antipyretics for fever, bedside wound care). * Grade II: Pharmacological treatment (e.g., antibiotics for infection). * Grade III: Surgical/endoscopic intervention (IIIa: local anesthesia; IIIb: general anesthesia). * Grade IV: Life-threatening (IVa: single-organ dysfunction; IVb: multi-organ failure). * Grade V: Death.
Adequate portal flow modulation response rate
The proportion of patients achieving target hemodynamic parameters following intervention (octreotide or splenic artery ligation), defined as: * Portal venous flow (PVF) \<5 mL/min/graft weight and * Presence of diastolic hepatic arterial flow on Doppler ultrasound post-intervention.
Median portal venous flow (PVF) rate on intraoperative Liver Doppler ultrasound
Portal venous flow (PVF): Volume flow rate (mL/min) normalized to graft weight (mL/min/g)
Median Hepatic artery resistive index (RI) on intraoperative Liver Doppler ultrasound
Hepatic artery resistive index (RI): (Peak systolic velocity - End diastolic velocity)
Hepatic artery diastolic flow rate
Binary presence or absence rate of end- diastolic flow on Liver Doppler Ultrasound
Median intensive care unit length of stay in days
Total number of days in the Intensive care unit (ICU) during the primary admission, from the day of transplant (Day 0) until discharge to the surgical ward.
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