Major Liver ResectionPhase 2NCT03179995
Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy
A Phase 2 study testing Octreotide in people with Major Liver Resection, run by Fox Chase Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Liver Resection
- What is being tested?
- Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2017to 12 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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.
- Conditions
- Major Liver Resection
- Being tested
- Octreotide, Placebo
- Keywords
- Octreotide, Major Liver Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
PlaceboOther
Normal saline will be administered in the same fashion as Octreotide
| Study group | Role | What they receive |
|---|---|---|
| Octreotide treatment arm | Experimental | Octreotide will be administered post-operatively until day 5 Receives: Drug: Octreotide |
| Placebo Arm | Placebo comparator | Normal saline will be administered post-operatively until day 5 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start7 Jul 2017
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Why it stopped: Grantor closed study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Liver ResectionStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Reddy, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179995
- Sponsor's protocol ID
- 17-1024
- Other IDs
- GI-072
- Status last verified
- Jan 2024
- First submitted
- 6 Jun 2017
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy
- ClinicalTrials.gov ID
- NCT03179995
- Acronym / sponsor ID
- 17-1024
- Conditions
- Major Liver Resection
- Keywords
- Octreotide, Major Liver Resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grantor closed study
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 26 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide treatment arm | Experimental | Drug: OctreotideOctreotide will be administered post-operatively until day 5 |
| Placebo Arm | Placebo comparator | Other: PlaceboNormal saline will be administered post-operatively until day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctreotideOctreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption. | Drug | Octreotide treatment arm |
| PlaceboNormal saline will be administered in the same fashion as Octreotide | Other | Placebo Arm |
Primary outcome
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
To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy.
2 secondary outcomes
Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy.
Time frame: 14 weeks
Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall.
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Major Liver Resection
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Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
RecruitingPhase 1/2
Safety of HRX215 in Patients After Minor and Major Liver Resection
Liver Resection, Colorectal Carcinoma Liver Metastases
RecruitingPhase 2
Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma
Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Reddy, MD principal investigator
Fox Chase Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Octreotide in people with Major Liver Resection, run by Fox Chase Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.