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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:
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 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.
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
Study Design
Key Assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Splenic Artery Ligation (SAL) Arm | Active Comparator | Intraoperative ligation of the splenic artery using non-absorbable suture near its origin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Diagnostic Criteria
| 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.
| From the day of liver transplantation (Day 0) through postoperative day 90 |
| Adequate portal flow modulation response rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center | Riyadh | 12713 | Saudi Arabia |
De-identified individual participant data will be made available, including baseline demographic and clinical characteristics, detailed intervention parameters, outcome measures , and adverse event records. Supporting study documents including the final study protocol, statistical analysis plan, case report forms, and clinical study report synopsis will be shared to facilitate interpretation. These data will become accessible 12 months after publication of the primary study findings and remain available for ten years through a secure data repository.
Start date: Publication of the study. End date: One year after publication of the study
Qualified researchers may request access by submitting a methodologically sound proposal for approval by the Principal Investigators and Data Monitoring Committee.
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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.
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Biostatistician
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| 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. |
|
The proportion of patients achieving target hemodynamic parameters following intervention (octreotide or splenic artery ligation), defined as:
| 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 |
Hepatic artery resistive index (RI): (Peak systolic velocity - End diastolic velocity) |
| Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge |
| Hepatic artery diastolic flow rate | Binary presence or absence rate of end- diastolic flow on Liver Doppler Ultrasound | Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge |
| 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. | 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 | Total number of days patient hospitalized during the index procedure | From the day of liver transplantation (Day 0) until hospital discharge (typically day 20 postoperatively) |
| Graft survival rate at 1-year post-transplantation | The proportion of patients with a functional liver graft (alive without retransplantation) at 1 year post-transplant, analyzed by including all graft losses (death or retransplantation) using the Kaplan-Meier test. | From the day of liver transplantation (Day 0) through postoperative day 365 |
| Patient survival rate at 1-year post-transplantation | The proportion of patients with alive at 1 year post-transplant, analyzed using the Kaplan-Meier test. | From the day of liver transplantation (Day 0) through postoperative day 365 |
| Quality of Life Assessment (36-Item Short Form Health Survey, SF-36) (median values) | The 36-Item Short Form Health Survey (SF-36) is a validated patient-reported outcome measure that assesses health-related quality of life. The SF-36 consists of eight subscales, which are further summarized into two component scores:
Scoring: Each subscale is scored from 0 to 100, where higher scores indicate better health-related quality of life. The median scores will be compared between the two groups. | Measured at baseline (pre-transplant), 3 months, 6 months, and 12 months post-transplantation. |
| Principal Investigator |
| Massimo Malago, MD, PhD | Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia | Principal Investigator |
| ID | Term |
|---|---|
| D015282 | Octreotide |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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