{
"info": {
"nct_id": "NCT01642875",
"official_title": "Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial",
"inclusion_criteria": "* Primary periampullary tumor\n* R0, R1 resection\n* Chronic pancreatitis requiring pancreatoduodenectomy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Metastatic tumor\n* Locally unresectable tumor\n* Previous gastric resection\n* ASA IV-V\n* Age under 18 years\n* Preoperative complete parenteral or enteral feeding\n* Immunosuppressive therapy before operation\n* Severe malnutrition\n* Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Primary periampullary tumor",
"criterions": [
{
"exact_snippets": [
"Primary periampullary tumor"
],
"criterion": "periampullary tumor",
"requirement_type": "primary",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Primary periampullary tumor"
],
"criterion": "periampullary tumor",
"requirement_type": "primary",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "* R0, R1 resection",
"criterions": [
{
"exact_snippets": [
"R0, R1 resection"
],
"criterion": "resection",
"requirement_type": "type",
"expected_value": [
"R0",
"R1"
]
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"R0, R1 resection"
],
"criterion": "resection",
"requirement_type": "type",
"expected_value": [
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"R1"
]
}
]
}
},
{
"identified_line": {
"line": "* Chronic pancreatitis requiring pancreatoduodenectomy",
"criterions": [
{
"exact_snippets": [
"Chronic pancreatitis"
],
"criterion": "chronic pancreatitis",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"requiring pancreatoduodenectomy"
],
"criterion": "pancreatoduodenectomy",
"requirement_type": "necessity",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Chronic pancreatitis"
],
"criterion": "chronic pancreatitis",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"requiring pancreatoduodenectomy"
],
"criterion": "pancreatoduodenectomy",
"requirement_type": "necessity",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": [
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],
"criterion": "healthy volunteers",
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"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Metastatic tumor",
"criterions": [
{
"exact_snippets": [
"Metastatic tumor"
],
"criterion": "tumor",
"requirement_type": "metastasis",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Metastatic tumor"
],
"criterion": "tumor",
"requirement_type": "metastasis",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* Locally unresectable tumor",
"criterions": [
{
"exact_snippets": [
"Locally unresectable tumor"
],
"criterion": "tumor",
"requirement_type": "resectability",
"expected_value": "locally unresectable"
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Locally unresectable tumor"
],
"criterion": "tumor",
"requirement_type": "resectability",
"expected_value": "locally unresectable"
}
}
},
{
"identified_line": {
"line": "* Previous gastric resection",
"criterions": [
{
"exact_snippets": [
"Previous gastric resection"
],
"criterion": "gastric resection",
"requirement_type": "history",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Previous gastric resection"
],
"criterion": "gastric resection",
"requirement_type": "history",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* ASA IV-V",
"criterions": [
{
"exact_snippets": [
"ASA IV-V"
],
"criterion": "ASA classification",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4
},
{
"operator": "<=",
"value": 5
}
]
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"ASA IV-V"
],
"criterion": "ASA classification",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4
},
{
"operator": "<=",
"value": 5
}
]
}
}
}
},
{
"identified_line": {
"line": "* Age under 18 years",
"criterions": [
{
"exact_snippets": [
"Age under 18 years"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Age under 18 years"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
}
}
},
{
"identified_line": {
"line": "* Preoperative complete parenteral or enteral feeding",
"criterions": [
{
"exact_snippets": [
"Preoperative complete parenteral or enteral feeding"
],
"criterion": "parenteral feeding",
"requirement_type": "preoperative",
"expected_value": true
},
{
"exact_snippets": [
"Preoperative complete parenteral or enteral feeding"
],
"criterion": "enteral feeding",
"requirement_type": "preoperative",
"expected_value": true
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": [
"Preoperative complete parenteral or enteral feeding"
],
"criterion": "parenteral feeding",
"requirement_type": "preoperative",
"expected_value": true
},
{
"exact_snippets": [
"Preoperative complete parenteral or enteral feeding"
],
"criterion": "enteral feeding",
"requirement_type": "preoperative",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "* Immunosuppressive therapy before operation",
"criterions": [
{
"exact_snippets": [
"Immunosuppressive therapy before operation"
],
"criterion": "immunosuppressive therapy",
"requirement_type": "timing",
"expected_value": "before operation"
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Immunosuppressive therapy before operation"
],
"criterion": "immunosuppressive therapy",
"requirement_type": "timing",
"expected_value": "before operation"
}
}
},
{
"identified_line": {
"line": "* Severe malnutrition",
"criterions": [
{
"exact_snippets": [
"Severe malnutrition"
],
"criterion": "malnutrition",
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Severe malnutrition"
],
"criterion": "malnutrition",
"requirement_type": "severity",
"expected_value": "severe"
}
}
},
{
"identified_line": {
"line": "* Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia",
"criterions": [
{
"exact_snippets": [
"Lack of the patient's consent for the trial participation"
],
"criterion": "patient's consent",
"requirement_type": "presence",
"expected_value": false
},
{
"exact_snippets": [
"Lack of the patient's consent for",
"feeding tube insertion"
],
"criterion": "patient's consent for feeding tube insertion",
"requirement_type": "presence",
"expected_value": false
},
{
"exact_snippets": [
"Lack of the patient's consent for",
"epidural analgesia"
],
"criterion": "patient's consent for epidural analgesia",
"requirement_type": "presence",
"expected_value": false
}
]
},
"logical_structure": {
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"and_criteria": [
{
"exact_snippets": [
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],
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"requirement_type": "presence",
"expected_value": false
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{
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],
"criterion": "patient's consent for feeding tube insertion",
"requirement_type": "presence",
"expected_value": false
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},
{
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],
"criterion": "patient's consent for epidural analgesia",
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}