{
    "info": {
        "nct_id": "NCT06421220",
        "official_title": "Clinical Efficacy and Safety Evaluation of Submucosal Injection of Indocyanine Green Tracer in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer: a Prospective, a Multicenter, Randomized, Controlled Study Clinical Trial",
        "inclusion_criteria": "Age: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage.\n\nPreoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs.\n\nPreoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery.\n\nPulmonary function test FEV1 <50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Age: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage.",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion",
                    "criterion": "gastric adenocarcinoma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histopathologically by endoscopic biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage",
                    "criterion": "preoperative clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT1-4a, N-/+, M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Preoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs.",
            "criterions": [
                {
                    "exact_snippets": "Preoperative examination did not show distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor did not directly invade the pancreas",
                    "criterion": "tumor invasion of pancreas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor did not directly invade the ... spleen",
                    "criterion": "tumor invasion of spleen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor did not directly invade the ... other adjacent organs",
                    "criterion": "tumor invasion of other adjacent organs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Preoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent",
            "criterions": [
                {
                    "exact_snippets": "Preoperative ECOG physical status score 0/1",
                    "criterion": "ECOG physical status score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative ASA score I-III",
                    "criterion": "ASA score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient 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 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 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": "Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or nursing women",
                    "criterion": "pregnancy or nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious mental illness",
                    "criterion": "serious mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of upper abdominal surgery (except history of laparoscopic cholecystectomy)",
                    "criterion": "history of upper abdominal surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of gastric surgery (including ESD/EMR for gastric cancer)",
                    "criterion": "history of gastric surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm)",
                    "criterion": "regional fusion of enlarged lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "suggestive imaging",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of other malignant diseases within 5 years",
                    "criterion": "history of other malignant diseases",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Neoadjuvant therapy has been implemented",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "implementation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of unstable angina or myocardial infarction within 6 months",
                    "criterion": "history of unstable angina or myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cerebral infarction or cerebral hemorrhage within 6 months",
                    "criterion": "history of cerebral infarction or cerebral hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of continuous systemic corticosteroid therapy within 1 month",
                    "criterion": "history of continuous systemic corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Require concomitant surgical treatment for other diseases",
                    "criterion": "requirement for concomitant surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery",
                    "criterion": "gastric cancer complications requiring emergency surgery",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary function test FEV1 <50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary function test FEV1 <50% of the expected value",
                    "criterion": "FEV1",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "% of the expected value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Diffusely invasive gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "diffusely invasive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperatively confirmed tumor invading the dentate line or duodenum",
                    "criterion": "tumor invasion",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "dentate line",
                                "duodenum"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous history of iodine allergy",
                    "criterion": "iodine allergy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Refusal of laparoscopic surgery",
                    "criterion": "laparoscopic surgery",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}