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| ID | Type | Description | Link |
|---|---|---|---|
| GI-072 | Other Identifier | Fox Chase Cancer Center |
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Grantor closed study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide treatment arm | Experimental | Octreotide will be administered post-operatively until day 5 |
|
| Placebo Arm | Placebo Comparator | Normal saline will be administered post-operatively until day 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall. |
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Inclusion Criteria:
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.
Q-T Interval of ≤ 450 ms as measured by EKG.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Reddy, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States | ||
| Temple University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Octreotide Treatment Arm | Octreotide 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. |
| FG001 | Placebo Arm | Normal saline will be administered post-operatively until day 5 Placebo: Normal saline will be administered in the same fashion as Octreotide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Octreotide Treatment Arm | Octreotide 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. |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data were not collected | Posted | 0 to 120 hours post dose |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Octreotide Treatment Arm | Octreotide 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| QT prolongation | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Protocol Development Coordinator | Fox Chase Cancer Center | 215-728-4097 | ryan.romasko@fccc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2019 | Apr 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Placebo | Other | Normal saline will be administered in the same fashion as Octreotide |
|
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 |
| Philadelphia |
| Pennsylvania |
| 19140 |
| United States |
Normal saline will be administered post-operatively until day 5 Placebo: Normal saline will be administered in the same fashion as Octreotide |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Data were not collected | Posted | 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). | Data were not collected | Posted | 3 months |
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 6 |
| 11 |
| EG001 | Placebo Arm | Normal 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 |
| Septic shock | Hepatobiliary disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Bilateral leg swelling | General disorders | Systematic Assessment |
|
| lactate dehydrogenase increase | General disorders | Systematic Assessment |
|
| septic shock due to infected biloma | Infections and infestations | Systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |