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

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.

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).

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.

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.

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.

Portal venous flow (PVF): Volume flow rate (mL/min) normalized to graft weight (mL/min/g)

Hepatic artery resistive index (RI): (Peak systolic velocity - End diastolic velocity)

Binary presence or absence rate of end- diastolic flow on Liver Doppler Ultrasound

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.

Total number of days patient hospitalized during the index procedure

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.

The proportion of patients with alive at 1 year post-transplant, analyzed using the Kaplan-Meier test.

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.