{
    "info": {
        "nct_id": "NCT03273920",
        "official_title": "Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial",
        "inclusion_criteria": "1. Pathologically proven gastric adenocarcinoma.\n2. Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.\n3. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. American Society of Anesthesiology (ASA) score of class I to III\n6. Patients who freely give informed consent to participate in the clinical study\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)\n2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)\n3. Gastric cancer-related complications (complete obstruction or perforation)\n4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging\n5. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer\n6. Patients diagnosed with other malignancy within 5 years\n7. Severe mental disorder\n8. Unstable angina or myocardial infarction within the past 6 months\n9. Cerebrovascular accident within the past 6 months\n10. Severe respiratory disease (FEV1< 50%)\n11. Continuous systemic steroid therapy within 1 month before the study\n12. Pregnant or breast-feeding women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Pathologically proven gastric adenocarcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Pathologically proven gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.",
            "criterions": [
                {
                    "exact_snippets": "Tumor located in the lower third of the stomach",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "lower third of the stomach"
                        }
                    ]
                },
                {
                    "exact_snippets": "possible to be curatively resected by subtotal gastrectomy",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "curatively resected by subtotal gastrectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition",
            "criterions": [
                {
                    "exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
                    "criterion": "cT stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
                    "criterion": "cN stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
                    "criterion": "cM stage",
                    "requirements": [
                        {
                            "requirement_type": "equality",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition",
                    "criterion": "staging system edition",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "American Joint Committee on Cancer/Union for International Cancer Control 8th edition"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. American Society of Anesthesiology (ASA) score of class I to III",
            "criterions": [
                {
                    "exact_snippets": "American Society of Anesthesiology (ASA) score of class I to III",
                    "criterion": "ASA score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "class"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "class"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients who freely give informed consent to participate in the clinical study",
            "criterions": [
                {
                    "exact_snippets": "Patients who freely give informed consent",
                    "criterion": "informed consent",
                    "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)",
            "criterions": [
                {
                    "exact_snippets": "Previous upper abdominal surgery",
                    "criterion": "previous upper abdominal surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except laparoscopic cholecystectomy",
                    "criterion": "laparoscopic cholecystectomy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)",
            "criterions": [
                {
                    "exact_snippets": "Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)",
                    "criterion": "previous gastric resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Gastric cancer-related complications (complete obstruction or perforation)",
            "criterions": [
                {
                    "exact_snippets": "Gastric cancer-related complications (complete obstruction or perforation)",
                    "criterion": "gastric cancer-related complications",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "complete obstruction",
                                "perforation"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging",
            "criterions": [
                {
                    "exact_snippets": "Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging",
                    "criterion": "regional lymph node",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer",
            "criterions": [
                {
                    "exact_snippets": "Previous neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous ... radiotherapy for gastric cancer",
                    "criterion": "radiotherapy for gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients diagnosed with other malignancy within 5 years",
            "criterions": [
                {
                    "exact_snippets": "Patients diagnosed with other malignancy within 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Severe mental disorder",
            "criterions": [
                {
                    "exact_snippets": "Severe mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Unstable angina or myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Cerebrovascular accident within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Cerebrovascular accident within the past 6 months",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Severe respiratory disease (FEV1< 50%)",
            "criterions": [
                {
                    "exact_snippets": "Severe respiratory disease",
                    "criterion": "respiratory disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "FEV1< 50%",
                    "criterion": "FEV1",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Continuous systemic steroid therapy within 1 month before the study",
            "criterions": [
                {
                    "exact_snippets": "Continuous systemic steroid therapy within 1 month before the study",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 1 month before the study"
                        },
                        {
                            "requirement_type": "continuity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Pregnant or breast-feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}