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 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT02626195
Eligibility Criteria:
Inclusion Criteria:
1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
2. Patients diagnosed with malnutrition (at least more than one)
1. PG-SGA B or C
2. Weight loss \>10% within 6 month
3. BMI \<18.5
4. Serum Albumin \<3.0
3. Age less than 80 years old over 20 years old
4. Performance status (ECOG scale): 0-1
5. Adequate organ functions
1. Hb ≥7.0 g/dl
2. ANC ≥1,500/mm3
3. PLT ≥80,000/mm3
4. Liver function: AST/ALT ≤5×upper limit of normal
5. Creatinine ≤2.0 ULN
Exclusion Criteria:
1. Biopsy, drainage tube insertion, and other minor surgery
2. palliative surgery
3. Serious illness or medical conditions, as follows;
1. congestive heart failure (NYHA class III or IV)
2. unstable angina or myocardial infarction within the past 6 months,
3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
4. uncontrolled hypertension
5. hepatic cirrhosis( ≥ Child class B)
6. interstitial pneumonia, pulmonary adenomatosis
7. psychiatric disorder that may interfere with and/or protocol compliance
8. unstable diabetes mellitus
9. uncontrolled ascites or pleural effusion
10. active infection
4. Pregnancy
5. Any patients judged by the investigator to be unfit to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02626195
Study Brief:
Protocol Section:
NCT02626195