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

King Faisal Specialist Hospital & Research Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Small-for-Size Syndrome

Treatments: Drug: Octreotide (drug); Procedure: Splenic Artery Ligation (SAL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06974344

RAC2241241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Octreotide Infusion Arm

Active Comparator group

Description:

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

Treatment:

Drug: Octreotide (drug)

Splenic Artery Ligation (SAL) Arm

Active Comparator group

Description:

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

Treatment:

Procedure: Splenic Artery Ligation (SAL)