Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

Temple University Health System (TUHS)

Status and phase: Terminated; Phase 2

Conditions: Major Liver Resection

Treatments: Other: Placebo; Drug: Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT03179995

17-1024

GI-072 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups, including a placebo group

Octreotide treatment arm

Experimental group

Description:

Octreotide will be administered post-operatively until day 5

Treatment:

Drug: Octreotide

Placebo Arm

Placebo Comparator group

Description:

Normal saline will be administered post-operatively until day 5

Treatment:

Other: Placebo