{
"info": {
"nct_id": "NCT00826982",
"official_title": "Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer",
"inclusion_criteria": "* Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases.\n* Patients who are scheduled for clinically indicated EUS\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease.\n* Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases.",
"criterions": [
{
"exact_snippets": "mass in the pancreas",
"criterion": "mass in the pancreas",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "suspicious for adenocarcinoma",
"criterion": "adenocarcinoma suspicion",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": true
}
]
},
{
"exact_snippets": "without biopsy proven distant metastases",
"criterion": "biopsy proven distant metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients who are scheduled for clinically indicated EUS",
"criterions": [
{
"exact_snippets": "Patients who are scheduled for clinically indicated EUS",
"criterion": "scheduled for clinically indicated EUS",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease.",
"criterions": [
{
"exact_snippets": "medically unfit for endoscopic sedation or surgery",
"criterion": "medical fitness for endoscopic sedation or surgery",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": false
}
]
},
{
"exact_snippets": "severe comorbid disease",
"criterion": "severe comorbid disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "uncontrolled coronary disease",
"criterion": "uncontrolled coronary disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "oxygen dependant pulmonary disease",
"criterion": "oxygen dependant pulmonary disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.",
"criterions": [
{
"exact_snippets": "any other malignancy other than basal cell carcinoma within the past 5 years",
"criterion": "other malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}