{
"info": {
"nct_id": "NCT05978882",
"official_title": "Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)",
"inclusion_criteria": "* single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography\n* tumor size: less than 3cm\n* location: 2cm far from the pylorus or cardia\n* aged 20 to 80\n* ECOG 0 or 1\n* patient who signed the agreement\n* patient who is suspected to underwent laparoscopic or robotic gastrectomy\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* indication of endoscopic submucosal resection\n* inoperable due to poor cardiac, and pulmonary function\n* pregnant\n* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen\n* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography",
"criterions": [
{
"exact_snippets": "single lesion of adenocarcinoma",
"criterion": "adenocarcinoma lesion",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": true
}
]
},
{
"exact_snippets": "clinical stage T1N0",
"criterion": "clinical stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "T1N0"
}
]
}
]
},
{
"line": "* tumor size: less than 3cm",
"criterions": [
{
"exact_snippets": "tumor size: less than 3cm",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* location: 2cm far from the pylorus or cardia",
"criterions": [
{
"exact_snippets": "location: 2cm far from the pylorus or cardia",
"criterion": "tumor location",
"requirements": [
{
"requirement_type": "distance",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "cm"
}
},
{
"requirement_type": "anatomical reference points",
"expected_value": [
"pylorus",
"cardia"
]
}
]
}
]
},
{
"line": "* aged 20 to 80",
"criterions": [
{
"exact_snippets": "aged 20 to 80",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* ECOG 0 or 1",
"criterions": [
{
"exact_snippets": "ECOG 0 or 1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "* patient who signed the agreement",
"criterions": [
{
"exact_snippets": "patient who signed the agreement",
"criterion": "agreement",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "* patient who is suspected to underwent laparoscopic or robotic gastrectomy",
"criterions": [
{
"exact_snippets": "suspected to underwent laparoscopic or robotic gastrectomy",
"criterion": "surgical procedure",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"laparoscopic gastrectomy",
"robotic gastrectomy"
]
},
{
"requirement_type": "status",
"expected_value": "suspected to have undergone"
}
]
}
]
},
{
"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": "* indication of endoscopic submucosal resection",
"criterions": [
{
"exact_snippets": "indication of endoscopic submucosal resection",
"criterion": "endoscopic submucosal resection",
"requirements": [
{
"requirement_type": "indication",
"expected_value": true
}
]
}
]
},
{
"line": "* inoperable due to poor cardiac, and pulmonary function",
"criterions": [
{
"exact_snippets": "inoperable due to poor cardiac",
"criterion": "cardiac function",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "poor"
}
]
},
{
"exact_snippets": "inoperable due to ... pulmonary function",
"criterion": "pulmonary function",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "poor"
}
]
}
]
},
{
"line": "* pregnant",
"criterions": [
{
"exact_snippets": "pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen",
"criterions": [
{
"exact_snippets": "having allergic reaction",
"criterion": "allergic reaction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "previous upper abdominal surgery except laparoscopic cholecystectomy",
"criterion": "previous upper abdominal surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "exclusion",
"expected_value": "laparoscopic cholecystectomy"
}
]
},
{
"exact_snippets": "previous radiation therapy to upper abdomen",
"criterion": "previous radiation therapy to upper abdomen",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer",
"criterions": [
{
"exact_snippets": "diagnosed as malignancy within 5 years",
"criterion": "malignancy diagnosis",
"requirements": [
{
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "except carcinoma in situ of cervix cancer",
"criterion": "carcinoma in situ of cervix cancer",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
},
{
"exact_snippets": "except ... thyroid cancer",
"criterion": "thyroid cancer",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}