Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

Phase 2

Terminated

• Conditions: Major Liver Resection
• Interventions: Drug: Octreotide; Other: Placebo

• Registration Number: NCT03179995
• Lead Sponsor: Fox Chase Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Study Start: 2017-07-07
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Results First Submitted: 2022-04-06
• Results First Submitted QC: 2022-05-04
• Results First Posted: 2022-05-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octreotide treatment arm	Octreotide	Octreotide will be administered post-operatively until day 5
Placebo Arm	Placebo	Normal saline will be administered post-operatively until day 5

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States