Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

NCT03179995 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 17-1024GI-072
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Liver Resection

Keywords

Octreotide, Major Liver Resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy.

  14 weeks

• Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall.

  3 months

Study Arms (2)

Octreotide treatment arm

EXPERIMENTAL

Octreotide will be administered post-operatively until day 5

Drug: Octreotide

Placebo Arm

PLACEBO COMPARATOR

Normal saline will be administered post-operatively until day 5

Other: Placebo

Interventions

Octreotide DRUG

Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.

Octreotide treatment arm

Placebo OTHER

Normal saline will be administered in the same fashion as Octreotide

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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.
• 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.
• Pregnant or breast feeding.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (2)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Protocol Development Coordinator
• Organization: Fox Chase Cancer Center

ryan.romasko@fccc.edu

215-728-4097

Study Officials

• Sanjay Reddy, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: July 7, 2017
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: February 14, 2024
• Results First Posted: May 26, 2022

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)