Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | July 7, 2017 |
| End Date: | June 30, 2022 |
| Contact: | Andreas Karachristos, MD |
| Email: | andreas.karachristos@fccc.edu |
| Phone: | 215-214-1515 |
GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy
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.
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.
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.
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