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

NCT06974344 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: RAC2241241
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small-for-Size Syndrome

Keywords

Living Donor Liver Transplantation; LDLT; Small-for-Size Graft; SFS; Portal Flow Modulation; Graft Inflow Modulation; Octreotide; Somatostatin Analogue; Splenic Artery Ligation,; SAL; Randomized Controlled Trial; RCT; Complications; Outcomes; Mortality; Liver Hemodynamics; Early Allograft Dysfunction; Small-for-Size Syndrome; SFSS; Survival

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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).

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

• 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.

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

• 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.

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

• Mortality rate

  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.

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

Secondary Outcomes (8)

• Median portal venous flow (PVF) rate on intraoperative Liver Doppler ultrasound

  Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge

• Median Hepatic artery resistive index (RI) on intraoperative Liver Doppler ultrasound

  Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge

• Hepatic artery diastolic flow rate

  Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge

• Median intensive care unit length of stay in days

  Days from admission to the Intensive Care Unit (ICU) (typically Day 0 to Day 4 postoperatively) until ICU discharge to the surgical ward.

• Median hospital length of stay in days

  From the day of liver transplantation (Day 0) until hospital discharge (typically day 20 postoperatively)

Study Arms (2)

Octreotide Infusion Arm

ACTIVE COMPARATOR

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

Drug: Octreotide (drug)

Splenic Artery Ligation (SAL) Arm

ACTIVE COMPARATOR

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

Procedure: Splenic Artery Ligation (SAL)

Interventions

Octreotide (drug) 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

Also known as: Octreotide acetate, Sandostatin®, Somatostatin analogue

Octreotide Infusion Arm

Splenic Artery Ligation (SAL) PROCEDURE

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.

Splenic Artery Ligation (SAL) Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and \<70 years
• Male and female genders
• Undergoing Living Donor Liver Transplant (LDLT)
• All indications
• Receiving a small-for-size graft requiring portal flow modulation
• Informed consent provided.

You may not qualify if:

• Deceased Donor Liver Transplantation (DDLT)
• Dual LDLT or dual LDLT/DDLT
• Pregnancy
• Known allergy to Octreotide / Somatostatin analogue

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

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

Riyadh, 12713, Saudi Arabia

Location

MeSH Terms

Interventions

Octreotide; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dieter C. Broering, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Dimitri A. Raptis, MD, MSc, PhD

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

  PRINCIPAL INVESTIGATOR

• Massimo Malago, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dieter C. Broering, MD, PhD

CONTACT

+966 11 464 7272; dbroering@kfshrc.edu.sa

Dimitri A. Raptis, MD, MSc, PhD

CONTACT

+966530330809; draptis@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Biostatistician
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group, randomized, single-blind trial comparing octreotide infusion versus splenic artery ligation for portal flow modulation in living donor liver transplantation. While participants are initially assigned to one treatment arm, crossover to the alternative therapy is permitted as rescue treatment if hemodynamic targets are not met. Outcome assessors will remain blinded to the original allocation throughout follow-up.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start date: Publication of the study. End date: One year after publication of the study
• Access Criteria: Qualified researchers may request access by submitting a methodologically sound proposal for approval by the Principal Investigators and Data Monitoring Committee.

Locations

SA (1)