Clinical trial NCT03179995: Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
Official title: GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Liver Resection
Keywords: Octreotide, Major Liver Resection
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Primary outcomes:
measure: Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group
timeFrame: 0 to 120 hours post dose
Secondary outcomes:
measure: Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy.
timeFrame: 14 weeks
measure: Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall.
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Sanjay Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: