{
    "info": {
        "nct_id": "NCT04016948",
        "official_title": "A Multicenter Randomized Study of Real-time In-vivo Confocal Laser Endomicroscopy Optical Biopsy for Distal Margin in Low Rectal Cancer Compared to Intraoperative Frozen Section",
        "inclusion_criteria": "* Ages from 18 to 70 years.\n* Rectal tumor confirmed pathologically by endoscopic biopsy.\n* The distance from lower edge of tumor to the dentate line is less than 5cm.\n* Plan to perform curative resection.\n* ASA(American Society of Anesthesiology)score class I,II,or III.\n* Able to provide written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Intestinal perforation or acute intestinal obstruction.\n* Multiple distant metastasis and can not R0 resection.\n* T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.\n* Pregnancy or breastfeeding.\n* Impaired renal function\n* American Society of Anesthesiology score (ASA) class IV or V.\n* Unable or refuse to provide written informed consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ages from 18 to 70 years.",
            "criterions": [
                {
                    "exact_snippets": "Ages from 18 to 70 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rectal tumor confirmed pathologically by endoscopic biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Rectal tumor confirmed pathologically by endoscopic biopsy",
                    "criterion": "rectal tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically by endoscopic biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The distance from lower edge of tumor to the dentate line is less than 5cm.",
            "criterions": [
                {
                    "exact_snippets": "distance from lower edge of tumor to the dentate line is less than 5cm",
                    "criterion": "distance from lower edge of tumor to the dentate line",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plan to perform curative resection.",
            "criterions": [
                {
                    "exact_snippets": "Plan to perform curative resection.",
                    "criterion": "curative resection",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ASA(American Society of Anesthesiology)score class I,II,or III.",
            "criterions": [
                {
                    "exact_snippets": "ASA(American Society of Anesthesiology)score class I,II,or III.",
                    "criterion": "ASA score",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide written informed consent.",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Intestinal perforation or acute intestinal obstruction.",
            "criterions": [
                {
                    "exact_snippets": "Intestinal perforation",
                    "criterion": "intestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute intestinal obstruction",
                    "criterion": "acute intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Multiple distant metastasis and can not R0 resection.",
            "criterions": [
                {
                    "exact_snippets": "Multiple distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                },
                {
                    "exact_snippets": "can not R0 resection",
                    "criterion": "R0 resection",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.",
            "criterions": [
                {
                    "exact_snippets": "T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4b"
                        },
                        {
                            "requirement_type": "staging system",
                            "expected_value": "AJCC Cancer Staging Manual Seventh Edition"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impaired renal function",
            "criterions": [
                {
                    "exact_snippets": "Impaired renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "impaired"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* American Society of Anesthesiology score (ASA) class IV or V.",
            "criterions": [
                {
                    "exact_snippets": "American Society of Anesthesiology score (ASA) class IV or V.",
                    "criterion": "American Society of Anesthesiology score (ASA)",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "IV",
                                "V"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable or refuse to provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Unable or refuse to provide written informed consent.",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability or willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}