Major Liver Resection
Conditions
Keywords
Octreotide, Major Liver Resection
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.
Interventions
DRUGOctreotide
Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
OTHERPlacebo
Normal saline will be administered in the same fashion as Octreotide
Sponsors
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group | 0 to 120 hours post dose | To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy. | 14 weeks | Hepatic parenchymal regeneration will be evaluated by hepatic volume measured by CT scan pre-operatively, at 1 week post-operatively and 3 months post operatively. |
| Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall. | 3 months | Evaluate the incidence of post-hepatectomy liver failure, bile leak, overall as well as 30-day and 90 day morbidity and mortality using American College of Surgeons-National Surgical Quality Improvement Definitions (ACS-NSQIP). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Octreotide Treatment Arm Octreotide will be administered post-operatively until day 5
Octreotide: Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption. | 11 |
| Placebo Arm Normal saline will be administered post-operatively until day 5
Placebo: Normal saline will be administered in the same fashion as Octreotide | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Octreotide Treatment Arm | Total | Placebo Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 7 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 16 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American Non-Hispanic | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 11 participants | 23 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 1 / 12 |
| other Total, other adverse events | 6 / 11 | 5 / 12 |
| serious Total, serious adverse events | 1 / 11 | 1 / 12 |
Outcome results
Primary
Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group
To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy.
Time frame: 0 to 120 hours post dose
Population: Data were not collected
Secondary
Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall.
Evaluate the incidence of post-hepatectomy liver failure, bile leak, overall as well as 30-day and 90 day morbidity and mortality using American College of Surgeons-National Surgical Quality Improvement Definitions (ACS-NSQIP).
Time frame: 3 months
Population: Data were not collected
Secondary
Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy.
Hepatic parenchymal regeneration will be evaluated by hepatic volume measured by CT scan pre-operatively, at 1 week post-operatively and 3 months post operatively.
Time frame: 14 weeks
Population: Data were not collected