{
"info": {
"nct_id": "NCT04211948",
"official_title": "Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer",
"inclusion_criteria": "* Diagnosed pancreatic ductal adenocarcinoma\n* Patients and their families volunteered to test and signed informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Preoperative exclusion:\n\n 1. Patients with metastasis (M1)\n 2. Patients with tumor recurrence\n 3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction\n 4. Patients with poor cardiopulmonary function cannot tolerate surgery;\n 5. receive neoadjuvant radiotherapy and chemotherapy before surgery;\n 6. The patient or family member refuses to join the group;\n 7. Pregnant patients\n* Intraoperative exclusion:\n\n 1. Intraoperative exploration of metastases in other parts besides the primary lesion\n 2. Other organs malignant tumors metastasize to the pancreas\n* Postoperative exclusion:\n\n 1. pathology confirmed non-pancreatic ductal adenocarcinoma",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Diagnosed pancreatic ductal adenocarcinoma",
"criterions": [
{
"exact_snippets": "Diagnosed pancreatic ductal adenocarcinoma",
"criterion": "pancreatic ductal adenocarcinoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients and their families volunteered to test and signed informed consent.",
"criterions": [
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Preoperative exclusion:",
"criterions": [
{
"exact_snippets": "Preoperative exclusion",
"criterion": "preoperative status",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "1. Patients with metastasis (M1)",
"criterions": [
{
"exact_snippets": "Patients with metastasis (M1)",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "2. Patients with tumor recurrence",
"criterions": [
{
"exact_snippets": "tumor recurrence",
"criterion": "tumor recurrence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction",
"criterions": [
{
"exact_snippets": "Patients with artery and/or vein invasion",
"criterion": "artery and/or vein invasion",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "can't perform radical resection and reconstruction",
"criterion": "ability to perform radical resection and reconstruction",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "4. Patients with poor cardiopulmonary function cannot tolerate surgery;",
"criterions": [
{
"exact_snippets": "Patients with poor cardiopulmonary function",
"criterion": "cardiopulmonary function",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "poor"
}
]
}
]
},
{
"line": "5. receive neoadjuvant radiotherapy and chemotherapy before surgery;",
"criterions": [
{
"exact_snippets": "receive neoadjuvant radiotherapy",
"criterion": "neoadjuvant radiotherapy",
"requirements": [
{
"requirement_type": "receipt",
"expected_value": true
}
]
},
{
"exact_snippets": "receive ... chemotherapy before surgery",
"criterion": "neoadjuvant chemotherapy",
"requirements": [
{
"requirement_type": "receipt",
"expected_value": true
}
]
}
]
},
{
"line": "6. The patient or family member refuses to join the group;",
"criterions": [
{
"exact_snippets": "The patient ... refuses to join the group",
"criterion": "patient consent",
"requirements": [
{
"requirement_type": "consent",
"expected_value": true
}
]
},
{
"exact_snippets": "family member refuses to join the group",
"criterion": "family member consent",
"requirements": [
{
"requirement_type": "consent",
"expected_value": true
}
]
}
]
},
{
"line": "7. Pregnant patients",
"criterions": [
{
"exact_snippets": "Pregnant patients",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "* Intraoperative exclusion:",
"criterions": [
{
"exact_snippets": "Intraoperative exclusion",
"criterion": "intraoperative exclusion",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "1. Intraoperative exploration of metastases in other parts besides the primary lesion",
"criterions": [
{
"exact_snippets": "Intraoperative exploration of metastases",
"criterion": "metastases",
"requirements": [
{
"requirement_type": "location",
"expected_value": "other parts besides the primary lesion"
}
]
}
]
},
{
"line": "2. Other organs malignant tumors metastasize to the pancreas",
"criterions": [
{
"exact_snippets": "Other organs malignant tumors metastasize to the pancreas",
"criterion": "malignant tumors",
"requirements": [
{
"requirement_type": "metastasis",
"expected_value": "pancreas"
}
]
}
]
},
{
"line": "* Postoperative exclusion:",
"criterions": [
{
"exact_snippets": "Postoperative exclusion",
"criterion": "postoperative status",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "1. pathology confirmed non-pancreatic ductal adenocarcinoma",
"criterions": [
{
"exact_snippets": "pathology confirmed non-pancreatic ductal adenocarcinoma",
"criterion": "non-pancreatic ductal adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "pathology"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}