{
    "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": [
        {
            "line": "* Primary periampullary tumor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Primary periampullary tumor"
                    ],
                    "criterion": "periampullary tumor",
                    "requirement_type": "primary",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* R0, R1 resection",
            "criterions": [
                {
                    "exact_snippets": [
                        "R0, R1 resection"
                    ],
                    "criterion": "resection",
                    "requirement_type": "type",
                    "expected_value": [
                        "R0",
                        "R1"
                    ]
                }
            ]
        },
        {
            "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
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "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
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Metastatic tumor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Metastatic tumor"
                    ],
                    "criterion": "tumor",
                    "requirement_type": "metastasis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Locally unresectable tumor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Locally unresectable tumor"
                    ],
                    "criterion": "tumor",
                    "requirement_type": "resectability",
                    "expected_value": "locally unresectable"
                }
            ]
        },
        {
            "line": "* Previous gastric resection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous gastric resection"
                    ],
                    "criterion": "gastric resection",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "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
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Age under 18 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age under 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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
                }
            ]
        },
        {
            "line": "* Immunosuppressive therapy before operation",
            "criterions": [
                {
                    "exact_snippets": [
                        "Immunosuppressive therapy before operation"
                    ],
                    "criterion": "immunosuppressive therapy",
                    "requirement_type": "timing",
                    "expected_value": "before operation"
                }
            ]
        },
        {
            "line": "* Severe malnutrition",
            "criterions": [
                {
                    "exact_snippets": [
                        "Severe malnutrition"
                    ],
                    "criterion": "malnutrition",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        },
        {
            "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
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}