Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

Study Overview
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Brief Summary
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This will be a prospective, randomized, double blind trial enrolling patients who will undergo major liver resection. Patients will be randomized in a 1:1 ratio to receive either octreotide or placebo in the postoperative period. The patients will receive octreotide intravenously continuously for five days after operation. During this period the patients' health will be monitored by performing blood tests including complete metabolic profile, Complete Blood Count (CBC) with/diff., INR and PTT. The functioning of heart will also be monitored post-operatively by EKG. Up to 80 participants will be accrued over a 2 year period. Volumetric CT scans will be performed prior to hepatectomy, 1 week after hepatectomy and 3 months after hepatectomy to evaluate liver regeneration.

Official Title
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GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy

Conditions
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Major Liver Resection

Intervention / Treatment
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* Drug: Octreotide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have liver tumors requiring a major liver resection, defined as removing at least three anatomical segments in patients without liver disease and two segments in patients with cirrhosis/fibrosis of the liver. Age > 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients must have acceptable organ and marrow function as defined below: White Blood Cells > 2,000/mcL Absolute Neutrophil Count > 1,000/mcL Platelets > 80,000/mcL Alkaline Phosphatase < 2.5 times institutional upper limit of normal Aspartate Aminotransferase/Alanine aminotransferases < 5 times institutional upper limit of normal INR < 1.5 times institutional upper limit of normal Ability to understand and willingness to sign a written informed consent and HIPAA consent document. Q-T Interval of ≤ 450 ms as measured by EKG. Exclusion Criteria: Patients with known hypersensitivity to octreotide or somatostatin. Patients who are receiving any other investigational agents. Patients who are taking other medications that prolong QT interval. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide treatment arm<br>Octreotide will be administered post-operatively until day 5 | Drug: Octreotide<br>* Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.<br>|
| Placebo Comparator: Placebo Arm<br>Normal saline will be administered post-operatively until day 5 | Other: Placebo<br>* Normal saline will be administered in the same fashion as Octreotide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group | To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy. | 0 to 120 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy. | Hepatic parenchymal regeneration will be evaluated by hepatic volume measured by CT scan pre-operatively, at 1 week post-operatively and 3 months post operatively. | 14 weeks | 
| Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall. | Evaluate the incidence of post-hepatectomy liver failure, bile leak, overall as well as 30-day and 90 day morbidity and mortality using American College of Surgeons-National Surgical Quality Improvement Definitions (ACS-NSQIP). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Octreotide, Major Liver Resection