{
    "info": {
        "nct_id": "NCT06389448",
        "official_title": "Comparison of Probe-based Confocal Laser Endomicroscopy and Traditional Endoscopic Biopsies in the Diagnosis of Gastric Cancer and Precancerous Lesions: a Prospective Multicenter Comparative Study",
        "inclusion_criteria": "* Over 18 years old and under 75 years old;\n* Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery;\n* Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery;\n* Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center).\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients with advanced gastric cancer or previous gastrectomy;\n* Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;\n* Patients who have a positive result in the fluorescein sodium allergy test;\n* Pregnant and lactating women;\n* Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign informed consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Over 18 years old and under 75 years old;",
            "criterions": [
                {
                    "exact_snippets": "Over 18 years old and under 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery;",
            "criterions": [
                {
                    "exact_snippets": "pathological diagnosis of LGIN, HGIN or early gastric cancer",
                    "criterion": "pathological diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "LGIN",
                                "HGIN",
                                "early gastric cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion has clear boundaries under endoscopic observation",
                    "criterion": "lesion boundaries",
                    "requirements": [
                        {
                            "requirement_type": "clarity",
                            "expected_value": "clear"
                        }
                    ]
                },
                {
                    "exact_snippets": "to be admitted for ESD surgery",
                    "criterion": "admission for ESD surgery",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery;",
            "criterions": [
                {
                    "exact_snippets": "meet the indications for endoscopic resection of early gastric cancer",
                    "criterion": "indications for endoscopic resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LGIN patients who intend to undergo ESD surgery",
                    "criterion": "LGIN patients",
                    "requirements": [
                        {
                            "requirement_type": "intention to undergo ESD surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center).",
            "criterions": [
                {
                    "exact_snippets": "able to provide pathological specimens/sections of previous endoscopic biopsy",
                    "criterion": "pathological specimens/sections of previous endoscopic biopsy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "it should be a case of this center",
                    "criterion": "case of this center",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": "this center"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients with advanced gastric cancer or previous gastrectomy;",
            "criterions": [
                {
                    "exact_snippets": "advanced gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous gastrectomy",
                    "criterion": "gastrectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;",
            "criterions": [
                {
                    "exact_snippets": "severe cardiopulmonary dysfunction",
                    "criterion": "cardiopulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "liver cirrhosis",
                    "criterion": "liver cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "renal dysfunction",
                    "criterion": "renal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal-gastro varices",
                    "criterion": "esophageal-gastro varices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have a positive result in the fluorescein sodium allergy test;",
            "criterions": [
                {
                    "exact_snippets": "positive result in the fluorescein sodium allergy test",
                    "criterion": "fluorescein sodium allergy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and lactating women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign informed consent.",
            "criterions": [
                {
                    "exact_snippets": "psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to cooperate with endoscopy",
                    "criterion": "ability to cooperate with endoscopy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to ... sign informed consent",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}