Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

Major Liver Resection Clinical Trial

Official title:

GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03179995
• Other study ID #: 17-1024
• Secondary ID: GI-072
• Status: Terminated
• Phase: Phase 2
• Start date: July 7, 2017
• Est. completion date: February 12, 2020

Study information

• Verified date: January 2024
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Major Liver Resection

Intervention

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.

Other:
• Placebo
Normal saline will be administered in the same fashion as Octreotide

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0 to 120 hours post dose
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.	14 weeks
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).	3 months