{
    "info": {
        "nct_id": "NCT03499782",
        "official_title": "A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Non-primary gallbladder or cholangiocarcinoma\n* With distant metastasis (M1 phase)\n* Incomplete follow-up data\n* Died within 30 days after surgery.",
        "miscellaneous_criteria": "Inclusion Criteria：\n\n* Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results\n* Must be able to undergo surgery\n* Undergoing radical surgery for biliary malignancy (R0 or R1 resection)\n* Not complicated with other malignancy\n* No other treatments before and during surgery, such as radiotherapy and chemotherapy."
    },
    "inclusion_lines": [
        {
            "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 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": "* Non-primary gallbladder or cholangiocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Non-primary gallbladder",
                    "criterion": "gallbladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "primary status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-primary ... cholangiocarcinoma",
                    "criterion": "cholangiocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "primary status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With distant metastasis (M1 phase)",
            "criterions": [
                {
                    "exact_snippets": "distant metastasis (M1 phase)",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "M1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Incomplete follow-up data",
            "criterions": [
                {
                    "exact_snippets": "Incomplete follow-up data",
                    "criterion": "follow-up data",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Died within 30 days after surgery.",
            "criterions": [
                {
                    "exact_snippets": "Died within 30 days after surgery.",
                    "criterion": "death after surgery",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "* Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results",
            "criterions": [
                {
                    "exact_snippets": "Clinical diagnosis of biliary malignancy",
                    "criterion": "biliary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gallbladder carcinoma",
                    "criterion": "gallbladder carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cholangiocarcinoma",
                    "criterion": "cholangiocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "verified by pathological results",
                    "criterion": "pathological verification",
                    "requirements": [
                        {
                            "requirement_type": "verification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be able to undergo surgery",
            "criterions": [
                {
                    "exact_snippets": "Must be able to undergo surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergoing radical surgery for biliary malignancy (R0 or R1 resection)",
            "criterions": [
                {
                    "exact_snippets": "Undergoing radical surgery for biliary malignancy",
                    "criterion": "surgery for biliary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "radical"
                        }
                    ]
                },
                {
                    "exact_snippets": "R0 or R1 resection",
                    "criterion": "resection margin status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "R0",
                                "R1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not complicated with other malignancy",
            "criterions": [
                {
                    "exact_snippets": "Not complicated with other malignancy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "complication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other treatments before and during surgery, such as radiotherapy and chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "No other treatments before and during surgery, such as radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other treatments before and during surgery, such as ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria：",
            "criterions": []
        }
    ]
}