{
"info": {
"nct_id": "NCT05768282",
"official_title": "Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia",
"inclusion_criteria": "* Histology from endoscopic biopsies showed squamous intraepithelial neoplasia without stromal invasion;\n* No lymph node metastasis on endoscopic ultrasound or computed tomography;\n* Magnifying endoscopy showed the intraepithelial papillary capillary loop as type B1 pattern, according to the classification of the microvascular architecture of superficial esophageal carcinoma.\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* A prior history of endoscopic resection, radiation therapy or esophagectomy for esophageal cancer;\n* A stricture that prevented the passage of a therapeutic endoscope;\n* Uncontrolled coagulopathy;\n* Poorly controlled diabetes mellitus.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histology from endoscopic biopsies showed squamous intraepithelial neoplasia without stromal invasion;",
"criterions": [
{
"exact_snippets": "Histology from endoscopic biopsies showed squamous intraepithelial neoplasia",
"criterion": "squamous intraepithelial neoplasia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "without stromal invasion",
"criterion": "stromal invasion",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No lymph node metastasis on endoscopic ultrasound or computed tomography;",
"criterions": [
{
"exact_snippets": "No lymph node metastasis on endoscopic ultrasound or computed tomography",
"criterion": "lymph node metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Magnifying endoscopy showed the intraepithelial papillary capillary loop as type B1 pattern, according to the classification of the microvascular architecture of superficial esophageal carcinoma.",
"criterions": [
{
"exact_snippets": "Magnifying endoscopy showed the intraepithelial papillary capillary loop as type B1 pattern",
"criterion": "intraepithelial papillary capillary loop pattern",
"requirements": [
{
"requirement_type": "classification",
"expected_value": "type B1"
}
]
}
]
},
{
"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": "* A prior history of endoscopic resection, radiation therapy or esophagectomy for esophageal cancer;",
"criterions": [
{
"exact_snippets": "prior history of endoscopic resection",
"criterion": "endoscopic resection",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "prior history of ... radiation therapy",
"criterion": "radiation therapy",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "prior history of ... esophagectomy for esophageal cancer",
"criterion": "esophagectomy for esophageal cancer",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* A stricture that prevented the passage of a therapeutic endoscope;",
"criterions": [
{
"exact_snippets": "A stricture that prevented the passage of a therapeutic endoscope",
"criterion": "stricture",
"requirements": [
{
"requirement_type": "effect",
"expected_value": "prevents passage of therapeutic endoscope"
}
]
}
]
},
{
"line": "* Uncontrolled coagulopathy;",
"criterions": [
{
"exact_snippets": "Uncontrolled coagulopathy",
"criterion": "coagulopathy",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
}
]
},
{
"line": "* Poorly controlled diabetes mellitus.",
"criterions": [
{
"exact_snippets": "Poorly controlled diabetes mellitus",
"criterion": "diabetes mellitus",
"requirements": [
{
"requirement_type": "control",
"expected_value": "poorly controlled"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}