Clinical trial NCT06974344: Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)
Official title: Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
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
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: This randomized controlled trial (SCALOP-RCT) investigates two strategies for managing portal hyperperfusion in adults receiving small living donor liver transplants (graft-to-recipient weight ratio \<0.80%). Small grafts are prone to injury from high venous portal and low hepatic artery flow, leading to small-for-size syndrome (SFSS), a major cause of transplant failure.

Interventions Compared

* Octreotide: A somatostatic analogue that reduces portal venous flow and increased hepatic artery flow to the liver by constricting blood vessels, given continuously through an IV during and after surgery.
* Splenic Artery Ligation (SAL): A surgical procedure that ties off the artery supplying the spleen, indirectly lowering portal venous flow.

Study Design

* Randomization: Participants are assigned 1:1 to octreotide or SAL during transplant surgery.
* Rescue Protocol: If portal venous flow remains too high after the initial treatment, patients may switch to the alternative therapy (crossover).
* Blinding: Surgeons know the treatment, but outcome assessors and data analysts do not.

Key Assessments

* Primary: Total complication burden at 90 days (Comprehensive Complication Index(R) (CCI(R)).
* Secondary: Blood flow measurements, early liver function, hospital stay, survival, and quality of life.
* Rationale: Current approaches vary widely, with no consensus on whether medications or surgery work better. This trial will provide evidence to standardize care, potentially improving graft survival and expanding donor options.
* Population: 80 adults (18-70 years) undergoing LDLT at a single tertiary center.
* Innovation: First head-to-head comparison of these strategies with rigorous hemodynamic monitoring and crossover rescue design.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Deceased Donor Liver Transplantation (DDLT)
2. Dual LDLT or dual LDLT/DDLT
3. Pregnancy
4. Known allergy to Octreotide / Somatostatin analogue

Primary outcomes:
measure: Median Comprehensive Complication Index® (CCI®)
timeFrame: From the day of liver transplantation (Day 0) through postoperative day 90.
measure: Small-for-size syndrome (SFSS) rate
timeFrame: From the day of liver transplantation (Day 0) through postoperative day 14
measure: Number and proportion of postoperative complication types and grades within 90 days
timeFrame: From the day of liver transplantation (Day 0) through postoperative day 90
measure: Adequate portal flow modulation response rate
timeFrame: From intervention completion (T=0) to 60 minutes post-intervention
measure: Mortality rate
timeFrame: From the day of liver transplantation (Day 0) through postoperative day 90
Secondary outcomes:
measure: Median portal venous flow (PVF) rate on intraoperative Liver Doppler ultrasound
timeFrame: Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge
measure: Median Hepatic artery resistive index (RI) on intraoperative Liver Doppler ultrasound
timeFrame: Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge
measure: Hepatic artery diastolic flow rate
timeFrame: Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge
measure: Median intensive care unit length of stay in days
timeFrame: Days from admission to the Intensive Care Unit (ICU) (typically Day 0 to Day 4 postoperatively) until ICU discharge to the surgical ward.
measure: Median hospital length of stay in days
timeFrame: From the day of liver transplantation (Day 0) until hospital discharge (typically day 20 postoperatively)
measure: Graft survival rate at 1-year post-transplantation
timeFrame: From the day of liver transplantation (Day 0) through postoperative day 365
measure: Patient survival rate at 1-year post-transplantation
timeFrame: From the day of liver transplantation (Day 0) through postoperative day 365
measure: Quality of Life Assessment (36-Item Short Form Health Survey, SF-36) (median values)
timeFrame: Measured at baseline (pre-transplant), 3 months, 6 months, and 12 months post-transplantation.
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center
Study officials:
affiliation: Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
name: Dieter C. Broering, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
name: Dimitri A. Raptis, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
name: Massimo Malago, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: