{
    "info": {
        "nct_id": "NCT05445973",
        "official_title": "Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance for Percutaneous Radiofrequency Ablation of Inconspicuous, Small Liver Tumors",
        "inclusion_criteria": "* inconspicuous or invisible index tumors for ablation on US\n* tumor size ≤ 3 cm\n* pathologic diagnosis of primary or secondary liver malignancy or imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines or viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm\n* consideration of curative-intent RFA\nHealthy volunteers allowed",
        "exclusion_criteria": "* well-visible tumors (visibility score of 3 or 4) on the planning B-mode US\n* the absence of available data from multiphase CT or MRI performed in the 3-month pre-procedure period\n* poor quality registration of US-CT/MRI fusion imaging and RFA planned with palliative intent\n* contraindications for the conventional RFA procedure at the authors' institution, which are uncontrollable coagulopathy (platelet count < 50,000/μL or international standard ratio ≥ 1.6), a low level of cooperation, impracticality of sedation, portal vein thrombus, the tumor abutting the portal vein, or larger bile ducts than the segmental branches",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* inconspicuous or invisible index tumors for ablation on US",
            "criterions": [
                {
                    "exact_snippets": "inconspicuous or invisible index tumors",
                    "criterion": "index tumors",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": [
                                "inconspicuous",
                                "invisible"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ablation on US",
                    "criterion": "ablation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "US"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* tumor size ≤ 3 cm",
            "criterions": [
                {
                    "exact_snippets": "tumor size ≤ 3 cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pathologic diagnosis of primary or secondary liver malignancy or imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines or viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm",
            "criterions": [
                {
                    "exact_snippets": "pathologic diagnosis of primary or secondary liver malignancy",
                    "criterion": "liver malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "pathologic"
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines",
                    "criterion": "HCC",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "imaging-based"
                        }
                    ]
                },
                {
                    "exact_snippets": "viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm",
                    "criterion": "viable HCC",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "Liver Imaging Reporting and Data System treatment response algorithm"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* consideration of curative-intent RFA",
            "criterions": [
                {
                    "exact_snippets": "consideration of curative-intent RFA",
                    "criterion": "curative-intent RFA",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* well-visible tumors (visibility score of 3 or 4) on the planning B-mode US",
            "criterions": [
                {
                    "exact_snippets": "well-visible tumors (visibility score of 3 or 4)",
                    "criterion": "tumor visibility",
                    "requirements": [
                        {
                            "requirement_type": "visibility score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on the planning B-mode US",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "planning B-mode US"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* the absence of available data from multiphase CT or MRI performed in the 3-month pre-procedure period",
            "criterions": [
                {
                    "exact_snippets": "absence of available data from multiphase CT or MRI",
                    "criterion": "multiphase CT or MRI data",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "performed in the 3-month pre-procedure period",
                    "criterion": "timeframe of multiphase CT or MRI",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "3-month pre-procedure period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* poor quality registration of US-CT/MRI fusion imaging and RFA planned with palliative intent",
            "criterions": [
                {
                    "exact_snippets": "poor quality registration of US-CT/MRI fusion imaging",
                    "criterion": "US-CT/MRI fusion imaging registration quality",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "RFA planned with palliative intent",
                    "criterion": "RFA intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "palliative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* contraindications for the conventional RFA procedure at the authors' institution, which are uncontrollable coagulopathy (platelet count < 50,000/μL or international standard ratio ≥ 1.6), a low level of cooperation, impracticality of sedation, portal vein thrombus, the tumor abutting the portal vein, or larger bile ducts than the segmental branches",
            "criterions": [
                {
                    "exact_snippets": "uncontrollable coagulopathy (platelet count < 50,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "/μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable coagulopathy ... international standard ratio ≥ 1.6",
                    "criterion": "international standard ratio",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "low level of cooperation",
                    "criterion": "level of cooperation",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "impracticality of sedation",
                    "criterion": "sedation",
                    "requirements": [
                        {
                            "requirement_type": "practicality",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "portal vein thrombus",
                    "criterion": "portal vein thrombus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor abutting the portal vein",
                    "criterion": "tumor abutting the portal vein",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "larger bile ducts than the segmental branches",
                    "criterion": "bile ducts size",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "larger than segmental branches"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}