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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01188733
Eligibility Criteria:
Inclusion Criteria:
1. Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
2. presence of small esophageal varices, defined as varices \< 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
3. age ≥ 18 years
Exclusion Criteria:
* pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
* allergic to sandostatin
* high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
* Child Turcotte Pugh Class C cirrhosis
* hepatocellular carcinoma
* evidence of ongoing alcohol or illicit drug abuse within 6 months of the study
* serum creatinine greater than 2 mg/dL
* platelet count below 50,000 per microliter
* prothrombin time 4 seconds or more greater than control
* human immunodeficiency virus (HIV) positive
* symptomatic gallstones
* previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena
* previous history of variceal bleeding
* history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation
* use of any investigational drug within 1 month prior to screening and
* current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01188733
Study Brief:
Protocol Section:
NCT01188733