Small-for-Size SyndromePhase 4SCALOPNCT06974344
Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)
A Phase 4 study testing Octreotide (drug) and Splenic Artery Ligation (SAL) in people with Small-for-Size Syndrome, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small-for-Size Syndrome
- What is being tested?
- Octreotide (drug) and Splenic Artery Ligation (SAL)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2025to 1 Sep 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Deceased Donor Liver Transplantation (DDLT)
- Dual LDLT or dual LDLT/DDLT
- Pregnancy
- Known allergy to Octreotide / Somatostatin analogue
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center
Riyadh, 12713
Dieter C. Broering, MD, PhD, +966 11 464 7272, dbroering@kfshrc.edu.sa
Dimitri A. Raptis, MD, MSc, PhD, +966530330809, draptis@kfshrc.edu.sa
About this study
Official title: Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation
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?
Read more
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.
Read the 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.
- Conditions
- Small-for-Size Syndrome
- Being tested
- Octreotide (drug), Splenic Artery Ligation (SAL)
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide (drug)Drug
Also called Octreotide acetate, Sandostatin®, Somatostatin analogue
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
Splenic Artery Ligation (SAL)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Octreotide (drug) |
| Splenic Artery Ligation (SAL) Arm | Active comparator | Intraoperative ligation of the splenic artery using non-absorbable suture near its origin. Receives: Procedure: Splenic Artery Ligation (SAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Portal venous flow (PVF): Volume flow rate (mL/min) normalized to graft weight (mL/min/g)
Measured: 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
Hepatic artery resistive index (RI): (Peak systolic velocity - End diastolic velocity)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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:
- Physical Component Summary (PCS): Includes physical functioning, role-physical, bodily pain, and general health.
- Mental Component Summary (MCS): Includes vitality, social functioning, role-emotional, and mental health.
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: Measured at baseline (pre-transplant), 3 months, 6 months, and 12 months post-transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-for-Size SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dieter C. Broering, MD, PhD, Principal investigator, Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi ArabiaDimitri A. Raptis, MD, MSc, PhD, Principal investigator, Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi ArabiaMassimo Malago, MD, PhD, Principal investigator, Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974344
- Sponsor's protocol ID
- RAC2241241
- Acronym
- SCALOP
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT06974344
- Acronym / sponsor ID
- SCALOP / RAC2241241
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Octreotide Infusion Arm | Active comparator | Drug: Octreotide (drug)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 | Procedure: Splenic Artery Ligation (SAL)Intraoperative ligation of the splenic artery using non-absorbable suture near its origin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Deceased Donor Liver Transplantation (DDLT)
- Dual LDLT or dual LDLT/DDLT
- Pregnancy
- Known allergy to Octreotide / Somatostatin analogue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide (drug)Also: Octreotide acetate, Sandostatin®, Somatostatin analogueContinuous 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 | Drug | Octreotide Infusion Arm |
| Splenic Artery Ligation (SAL)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. | Procedure or surgery | Splenic Artery Ligation (SAL) Arm |
Primary outcome
Median Comprehensive Complication Index® (CCI®)
Time frame: From the day of liver transplantation (Day 0) through postoperative day 90.
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.
Small-for-size syndrome (SFSS) rate
Time frame: From the day of liver transplantation (Day 0) through postoperative day 14
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).
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
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.
Adequate portal flow modulation response rate
Time frame: From intervention completion (T=0) to 60 minutes post-intervention
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.
Mortality rate
Time frame: From the day of liver transplantation (Day 0) through postoperative day 90
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.
8 secondary outcomes
Median portal venous flow (PVF) rate on intraoperative Liver Doppler ultrasound
Time frame: 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
Time frame: Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge
Hepatic artery diastolic flow rate
Time frame: Intraoperative (post-reperfusion) and postoperative (daily) timepoints until day 20 postoperatively or hospital discharge
Median intensive care unit length of stay in days
Time frame: 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
Time frame: From the day of liver transplantation (Day 0) until hospital discharge (typically day 20 postoperatively)
Graft survival rate at 1-year post-transplantation
Time frame: From the day of liver transplantation (Day 0) through postoperative day 365
Patient survival rate at 1-year post-transplantation
Time frame: 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)
Time frame: Measured at baseline (pre-transplant), 3 months, 6 months, and 12 months post-transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dieter C. Broering, MD, PhD principal investigator
Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
Dimitri A. Raptis, MD, MSc, PhD principal investigator
Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
Massimo Malago, MD, PhD principal investigator
Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Octreotide (drug) and Splenic Artery Ligation (SAL) in people with Small-for-Size Syndrome, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dieter C. Broering, MD, PhD (+966 11 464 7272, dbroering@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Comprehensive Complication Index® (CCI®) (time frame: From the day of liver transplantation (Day 0) through postoperative day 90.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.