Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

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.

Study Overview

• Status: Terminated
• Conditions: Major Liver Resection
• Intervention / Treatment: Drug: Octreotide; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Octreotide treatment arm; Octreotide will be administered post-operatively until day 5	Drug: Octreotide; Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
Placebo Comparator: Placebo Arm; Normal saline will be administered post-operatively until day 5	Other: Placebo; Normal saline will be administered in the same fashion as Octreotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 to 120 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 weeks
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).	3 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Investigators: Principal Investigator: Sanjay Reddy, MD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Octreotide, Major Liver Resection
• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: 17-1024; GI-072 (Other Identifier: Fox Chase Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No