{
"info": {
"nct_id": "NCT04056260",
"official_title": "Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer",
"inclusion_criteria": "* dignosed gastric adenocarcinoma\n* tumor: size 4cm or smaller\n* depth of invasion: mucosa, submucosa, proper muscle\n* candidates of laparoscopic radical gastrectomy\n* informed consent\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* metachronous malignancy\n* number of tumors: 2 or more\n* remnant gastric cancer\n* indication for endoscopic resection\n* history of chemotherapy or radiation therapy\n* pregnancy\n* allergy to ICG\n* metastatic gastric cancer",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* dignosed gastric adenocarcinoma",
"criterions": [
{
"exact_snippets": "dignosed gastric adenocarcinoma",
"criterion": "gastric adenocarcinoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "* tumor: size 4cm or smaller",
"criterions": [
{
"exact_snippets": "tumor: size 4cm or smaller",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* depth of invasion: mucosa, submucosa, proper muscle",
"criterions": [
{
"exact_snippets": "depth of invasion: mucosa, submucosa, proper muscle",
"criterion": "depth of invasion",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"mucosa",
"submucosa",
"proper muscle"
]
}
]
}
]
},
{
"line": "* candidates of laparoscopic radical gastrectomy",
"criterions": [
{
"exact_snippets": "candidates of laparoscopic radical gastrectomy",
"criterion": "surgical candidacy",
"requirements": [
{
"requirement_type": "procedure",
"expected_value": "laparoscopic radical gastrectomy"
}
]
}
]
},
{
"line": "* informed consent",
"criterions": [
{
"exact_snippets": "informed consent",
"criterion": "informed consent",
"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 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* metachronous malignancy",
"criterions": [
{
"exact_snippets": "metachronous malignancy",
"criterion": "metachronous malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* number of tumors: 2 or more",
"criterions": [
{
"exact_snippets": "number of tumors: 2 or more",
"criterion": "number of tumors",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* remnant gastric cancer",
"criterions": [
{
"exact_snippets": "remnant gastric cancer",
"criterion": "remnant gastric cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* indication for endoscopic resection",
"criterions": [
{
"exact_snippets": "indication for endoscopic resection",
"criterion": "indication for endoscopic resection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* history of chemotherapy or radiation therapy",
"criterions": [
{
"exact_snippets": "history of chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of ... radiation therapy",
"criterion": "radiation therapy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* pregnancy",
"criterions": [
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* allergy to ICG",
"criterions": [
{
"exact_snippets": "allergy to ICG",
"criterion": "allergy",
"requirements": [
{
"requirement_type": "substance",
"expected_value": "ICG"
}
]
}
]
},
{
"line": "* metastatic gastric cancer",
"criterions": [
{
"exact_snippets": "metastatic gastric cancer",
"criterion": "gastric cancer",
"requirements": [
{
"requirement_type": "metastasis",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}