Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT03179995
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03179995
Study Brief:
Protocol Section:
NCT03179995