Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

NCTNCT03179995Other id17-1024Other idGI-072

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Grantor closed study

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 23 participants (actual)
Sponsor: Fox Chase Cancer Center · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: 7 Jul 2017
Primary completion: 12 Feb 2020
Completion: 12 Feb 2020
First posted: 7 Jun 2017
Last update posted: 14 Feb 2024
Conditions: Major Liver Resection

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20172018201920202021

Ph 2
Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
NCT03179995
7 Jul 2017 to 12 Feb 2020
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

OctreotideDrug
PlaceboOther

Arms2

Experimental
Octreotide treatment arm
Octreotide will be administered post-operatively until day 5
Placebo comparator
Placebo Arm
Normal saline will be administered post-operatively until day 5

Primary outcomes1

Outcomes the sponsor listed as primary.

Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group
Time frame · 0 to 120 hours post dose
Registry description
To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy.

Secondary outcomes(2)

Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy.
Time frame · 14 weeks
Registry description
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.
Time frame · 3 months
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 0 to 120 hours post dose

Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group

Group	Value
Octreotide Treatment Arm	not posted
Placebo Arm	not posted

Secondary and other outcome results(2)

Secondary outcome· 14 weeks

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

Group	Value
Octreotide Treatment Arm	not posted
Placebo Arm	not posted

Secondary outcome· 3 months

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

Group	Value
Octreotide Treatment Arm	not posted
Placebo Arm	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Octreotide Treatment ArmOctreotide 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.	0 / 11	1 / 11	6 / 11
Placebo ArmNormal saline will be administered post-operatively until day 5 Placebo: Normal saline will be administered in the same fashion as Octreotide	1 / 12	1 / 12	5 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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