{
"info": {
"nct_id": "NCT04197180",
"official_title": "HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study",
"inclusion_criteria": "1. Low grade intraepithelial neoplasia of stomach with size≤20 mm\n2. Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN\n3. Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc\n4. Patients with informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "1. Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.\n2. Endoscopic evidence of ulcer\n3. Biopsy confirmed HGIN\n4. Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN\n5. Pregnancy\n6. informed consent not available",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Low grade intraepithelial neoplasia of stomach with size≤20 mm",
"criterions": [
{
"exact_snippets": "Low grade intraepithelial neoplasia of stomach",
"criterion": "intraepithelial neoplasia of stomach",
"requirements": [
{
"requirement_type": "grade",
"expected_value": "low"
}
]
},
{
"exact_snippets": "size≤20 mm",
"criterion": "neoplasia size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 20,
"unit": "mm"
}
}
]
}
]
},
{
"line": "2. Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN",
"criterions": [
{
"exact_snippets": "Endoscopic diagnosis suspected gastric LGIN",
"criterion": "gastric LGIN",
"requirements": [
{
"requirement_type": "diagnosis method",
"expected_value": "endoscopic"
},
{
"requirement_type": "diagnosis certainty",
"expected_value": "suspected"
}
]
},
{
"exact_snippets": "biopsy confirmed gastric LGIN",
"criterion": "gastric LGIN",
"requirements": [
{
"requirement_type": "diagnosis method",
"expected_value": "biopsy"
},
{
"requirement_type": "diagnosis certainty",
"expected_value": "confirmed"
}
]
}
]
},
{
"line": "3. Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc",
"criterions": [
{
"exact_snippets": "Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc",
"criterion": "endoscopic appearance",
"requirements": [
{
"requirement_type": "classification",
"expected_value": [
"Type 0-IIa",
"IIb",
"IIc"
]
}
]
}
]
},
{
"line": "4. Patients with informed consent",
"criterions": [
{
"exact_snippets": "Patients with 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 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 85 Years",
"criterions": [
{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.",
"criterions": [
{
"exact_snippets": "previous endoscopic treatment",
"criterion": "previous endoscopic treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "gastric LGIN, HGIN or gastric carcinoma",
"criterion": "gastric conditions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"gastric LGIN",
"HGIN",
"gastric carcinoma"
]
}
]
}
]
},
{
"line": "2. Endoscopic evidence of ulcer",
"criterions": [
{
"exact_snippets": "Endoscopic evidence of ulcer",
"criterion": "ulcer",
"requirements": [
{
"requirement_type": "detection method",
"expected_value": "endoscopic evidence"
}
]
}
]
},
{
"line": "3. Biopsy confirmed HGIN",
"criterions": [
{
"exact_snippets": "Biopsy confirmed HGIN",
"criterion": "HGIN",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "biopsy"
}
]
}
]
},
{
"line": "4. Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN",
"criterions": [
{
"exact_snippets": "Endoscopic diagnosis suspected HGIN",
"criterion": "endoscopic diagnosis",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": "HGIN"
}
]
},
{
"exact_snippets": "biopsy confirmed LGIN",
"criterion": "biopsy",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "LGIN"
}
]
}
]
},
{
"line": "5. Pregnancy",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "6. informed consent not available",
"criterions": [
{
"exact_snippets": "informed consent not available",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "availability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}