{
    "info": {
        "nct_id": "NCT02184182",
        "official_title": "Liver Resection After Portal Vein Ligation / Embolization and Transection Plane Devascularization With Radio Frequency / Microwave: Pilot Study on Primary and Secondary Liver Tumors",
        "inclusion_criteria": "* Patients aged between 18 and 70 years (M and F)\n* Liver tumors that interests the right hepatic lobe (segments 4,5,6,7,8) with possible involvement of the caudate lobe (segment 1) or bilobar disease with less than 3 lesions in the left lateral lobe without vascular involvement and amenable to surgically resectable or ablation in the Step1.\n* Absence of extrahepatic disease\n* Normal hepatic function (total bilirubin <3 mg / dL)\n* Performance status: ECOG 0\n* In case of liver cirrhosis MELD score <9\n* Patients without prior chemotherapy or with previous chemotherapy but with response disease\n* Patients who give their consent to the intervention\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* CT Evidence of involvement of the major vessels in the future remnant liver\n* Presence of more than 3 nodules in the left lateral lobe\n* Presence of extrahepatic disease\n* Severe hepatic impairment\n* Age> 70 years\n* Previous liver surgery (prior liver resections)\n* Patient receiving chemotherapy with documented disease progression",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients aged between 18 and 70 years (M and F)",
            "criterions": [
                {
                    "exact_snippets": "Patients aged between 18 and 70 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M and F",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "M",
                                "F"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver tumors that interests the right hepatic lobe (segments 4,5,6,7,8) with possible involvement of the caudate lobe (segment 1) or bilobar disease with less than 3 lesions in the left lateral lobe without vascular involvement and amenable to surgically resectable or ablation in the Step1.",
            "criterions": [
                {
                    "exact_snippets": "Liver tumors that interests the right hepatic lobe (segments 4,5,6,7,8)",
                    "criterion": "liver tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "right hepatic lobe (segments 4,5,6,7,8)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "possible involvement of the caudate lobe (segment 1)",
                    "criterion": "caudate lobe involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": "possible"
                        }
                    ]
                },
                {
                    "exact_snippets": "bilobar disease with less than 3 lesions in the left lateral lobe",
                    "criterion": "bilobar disease",
                    "requirements": [
                        {
                            "requirement_type": "lesion count",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "lesions"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without vascular involvement",
                    "criterion": "vascular involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to surgically resectable or ablation in the Step1",
                    "criterion": "surgical resectability or ablation",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of extrahepatic disease",
            "criterions": [
                {
                    "exact_snippets": "Absence of extrahepatic disease",
                    "criterion": "extrahepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal hepatic function (total bilirubin <3 mg / dL)",
            "criterions": [
                {
                    "exact_snippets": "Normal hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin <3 mg / dL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status: ECOG 0",
            "criterions": [
                {
                    "exact_snippets": "Performance status: ECOG 0",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "ECOG score",
                            "expected_value": "0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In case of liver cirrhosis MELD score <9",
            "criterions": [
                {
                    "exact_snippets": "liver cirrhosis",
                    "criterion": "liver cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MELD score <9",
                    "criterion": "MELD score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients without prior chemotherapy or with previous chemotherapy but with response disease",
            "criterions": [
                {
                    "exact_snippets": "Patients without prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous chemotherapy but with response disease",
                    "criterion": "response to previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who give their consent to the intervention",
            "criterions": [
                {
                    "exact_snippets": "Patients who give their consent",
                    "criterion": "consent to the intervention",
                    "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* CT Evidence of involvement of the major vessels in the future remnant liver",
            "criterions": [
                {
                    "exact_snippets": "CT Evidence of involvement of the major vessels",
                    "criterion": "involvement of the major vessels",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "CT"
                        }
                    ]
                },
                {
                    "exact_snippets": "future remnant liver",
                    "criterion": "future remnant liver",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of more than 3 nodules in the left lateral lobe",
            "criterions": [
                {
                    "exact_snippets": "Presence of more than 3 nodules in the left lateral lobe",
                    "criterion": "nodules in the left lateral lobe",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "nodules"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of extrahepatic disease",
            "criterions": [
                {
                    "exact_snippets": "Presence of extrahepatic disease",
                    "criterion": "extrahepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe hepatic impairment",
            "criterions": [
                {
                    "exact_snippets": "Severe hepatic impairment",
                    "criterion": "hepatic impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age> 70 years",
            "criterions": [
                {
                    "exact_snippets": "Age> 70 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous liver surgery (prior liver resections)",
            "criterions": [
                {
                    "exact_snippets": "Previous liver surgery (prior liver resections)",
                    "criterion": "liver surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient receiving chemotherapy with documented disease progression",
            "criterions": [
                {
                    "exact_snippets": "Patient receiving chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}