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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

80 participants (estimated)

Sponsor

King Faisal Specialist Hospital & Research Center · Other

Design

Randomized · Double masking

Countries

1 country

Saudi Arabia

Start

1 Jun 2025 (estimated)

Primary completion

1 May 2030 (estimated)

Completion

1 Sept 2030 (estimated)

First posted

15 May 2025

Last update posted

15 May 2025

Conditions

Small-for-Size Syndrome

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.

• Active comparator

  Octreotide Infusion Arm

  Continuous intravenous octreotide (1 mcg/kg/hr) initiated at liver graft reperfusion and continued postoperatively until hemodynamic stability is achieved.

• Active comparator

  Splenic Artery Ligation (SAL) Arm

  Intraoperative ligation of the splenic artery using non-absorbable suture near its origin.

1. Median Comprehensive Complication Index® (CCI®)

   Time frame · From the day of liver transplantation (Day 0) through postoperative day 90.

   Registry description

   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.

2. Small-for-size syndrome (SFSS) rate

   Time frame · From the day of liver transplantation (Day 0) through postoperative day 14

   Registry description

   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).

3. Number and proportion of postoperative complication types and grades within 90 days

   Time frame · From the day of liver transplantation (Day 0) through postoperative day 90

   Registry description

   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.

4. Adequate portal flow modulation response rate

   Time frame · From intervention completion (T=0) to 60 minutes post-intervention

   Registry description

   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.

5. Mortality rate

   Time frame · From the day of liver transplantation (Day 0) through postoperative day 90

   Registry description

   All-cause mortality occurring within 90 days post-transplantation, regardless of relationship to the intervention or underlying liver disease. This will the proportion of deaths over total number of patients within each arm and reported in percentage.

No study cites this trial.