Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy (NCT03179995) | Clinical Trial Compass
TerminatedPhase 2
Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
Stopped: Grantor closed study
United States23 participantsStarted 2017-07-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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.
What they're measuring
1
Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group
. 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.