{
"info": {
"nct_id": "NCT02558504",
"official_title": "Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus",
"inclusion_criteria": "* Age over 18 years,\n* General Condition WHO 0, 1 or 2,\n* ASA Class I and II, eligible for endoscopic or surgical treatment with curative intent,\n* Histological diagnosis of high grade glandular epithelial neoplasia (Vienna 4-1 to 4-46), possibly multifocal or stage 0 (Tis, N0, M0),\n* Endoscopic and histological confirmed diagnosis of intestinal metaplasia,\n* Histological diagnosis confirmed by two endoscopies with biopsies and two pathological readings; biopsies should be carried out according to the protocol of the SFED (four-quadrant biopsies every cm) with at least once acetic acid for staining. Operators describe Barrett's esophagus using he SFED planimetric model. The final exam will be no more than two months before the date of treatment and should have been achieved in investigator establishment,\n* Extension height of Barrett's esophagus upstream of the upper part of the gastric folds or palisade vessels:\n\n * Minimum 1 cm,\n * Maximum 12 cm.\n* In case of previous treatment by mucosal resection or submucosal dissection (DSM) for severe dysplasia or microinvasive carcinoma:\n\n * the resected lesion must have been well differentiated and confined to the muscular mucosa (m3 maximum) on histological analysis,\n * resection should be more than two months,\n * resection must have been macroscopically complete laterally,\n * resection must have been histologically complete in depth,\n * resection must have been histologically complete laterally with regard to the microinvasive cancer, that is to say with a clear margin of safety (margin may be high-grade dysplasia provided that the latter has not macroscopic translation),\n * At least one endoscopic and histologic follow-up should be conducted with dye in a period of less than two months before the date of treatment, and at the investigator establishment.\n* Patient may take an inhibitor of proton pump equivalent to 2 times 40 mg of esomeprazole,\n* No mediastinal or celiac, or suspected metastatic lymph nodes by EUS,\n* Affiliation to a social security system or similar,\n* Lack of participation in another clinical study,\n* Informed consent signed.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* - Aged under 18,\n* Lack of informed consent signed,\n* Radiofrequency treatment history,\n* on going neoplastic history with a short prognosis,\n* Concomitant participation in another clinical study\n* Contraindication to general anesthesia,\n* Patient with an esophageal location of scleroderma\n* Presence of a cardiac pacemaker or stimulator\n* Pregnant women or likely to be in the absence of effective contraception,\n* Esophageal stenosis preventing the passage of an endoscope,\n* Histology other than glandular neoplasia,\n* History of or current history of esophageal cancer invading the submucosal layer of the esophagus or more,\n* Surgical treatment history (except anti-reflux treatment) or esophageal radiotherapy,\n* previous esophageal treatment by another method ablation: photodynamic therapy, argon plasma coagulation, laser, ....\n* Esophageal varices observed in endoscopy,\n* Coagulopathy or taking anticoagulants responsible an INR> 1.3 or a platelet count <75,000 per microL,\n* Life expectancy of less than 3 years, due to intercurrent disease, especially neoplastic,\n* Severe Medical pathology:\n\n * Liver cirrhosis (Child-Pugh all stages)\n * Respiratory failure:\n\nVEMS (Maximum Expiratory Volume Second) <1L / min\n\nPaO2 <60 mmHg\n\nPaCO2> 45 mmHg\n\n* Renal failure (Cl Cr < 60 mL /min /1,73m²),\n* Heart attack within the last six months or progressive coronary artery disease,\n* Severe distal arteriopathie > stage II of Leriche and Fontaine",
"miscellaneous_criteria": ""
},
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{
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"Age over 18 years"
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"General Condition WHO 0, 1 or 2"
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"operator": ">=",
"value": 0
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"operator": "<=",
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"line": "* Histological diagnosis confirmed by two endoscopies with biopsies and two pathological readings; biopsies should be carried out according to the protocol of the SFED (four-quadrant biopsies every cm) with at least once acetic acid for staining. Operators describe Barrett's esophagus using he SFED planimetric model. The final exam will be no more than two months before the date of treatment and should have been achieved in investigator establishment,",
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"identified_line": {
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{
"exact_snippets": [
"Renal failure"
],
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"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"Cl Cr < 60 mL /min /1,73m²"
],
"criterion": "creatinine clearance",
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"value": 60
}
}
]
},
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"and_criteria": [
{
"exact_snippets": [
"Renal failure"
],
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"expected_value": true
},
{
"exact_snippets": [
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}
}
]
}
},
{
"identified_line": {
"line": "* Heart attack within the last six months or progressive coronary artery disease,",
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{
"exact_snippets": [
"Heart attack within the last six months"
],
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"requirement_type": "time since occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6
}
]
}
},
{
"exact_snippets": [
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],
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}
]
},
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{
"and_criteria": [
{
"exact_snippets": [
"Heart attack within the last six months"
],
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"comparisons": [
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"operator": "<=",
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]
}
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{
"exact_snippets": [
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"expected_value": true
}
]
}
]
}
},
{
"identified_line": {
"line": "* Severe distal arteriopathie > stage II of Leriche and Fontaine",
"criterions": [
{
"exact_snippets": [
"Severe distal arteriopathie"
],
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},
{
"exact_snippets": [
"> stage II of Leriche and Fontaine"
],
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{
"operator": ">",
"value": 2
}
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Severe distal arteriopathie"
],
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},
{
"exact_snippets": [
"> stage II of Leriche and Fontaine"
],
"criterion": "Leriche and Fontaine stage",
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 2
}
]
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}