Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
Condition: Major Liver Resection
Intervention: Octreotide; Placebo
Intervention description: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.; Normal saline will be administered in the same fashion as Octreotide
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Octreotide, Major Liver Resection

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Age > 18 years.

          3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

          4. 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

          5. Ability to understand and willingness to sign a written informed consent and HIPAA
             consent document.

          6. Q-T Interval of ≤ 450 ms as measured by EKG.

        Exclusion Criteria:

          1. Patients with known hypersensitivity to octreotide or somatostatin.

          2. Patients who are receiving any other investigational agents.

          3. Patients who are taking other medications that prolong QT interval.

          4. 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.

          5. Pregnant or breast feeding.