{
    "info": {
        "nct_id": "NCT01774019",
        "official_title": "Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer",
        "inclusion_criteria": "* Age 18 or older\n* Willing and able to comply with the study procedures and provide written informed consent to participate in the study\n* Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)\n* Biliary obstructive symptoms or signs\n* Bilirubin level at/above 100 umol per liter (5.8 mg/dL)\n* Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy\n* Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum\n* Patients deemed as resectable by pancreatic protocol CT or MRI\n* Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion\n* Surgery intent within 4 weeks\n* Endoscopic and surgical treatment to be provided by same team\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Biliary strictures caused by confirmed benign tumors\n* Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers\n* Surgically altered biliary tract anatomy, not including prior cholecystectomy\n* Neoadjuvant chemotherapy for current malignancy\n* Palliative indication due to reasons other than surgical candidate status\n* Previous biliary drainage by ERCP/PTC\n* Patients for whom endoscopic techniques are contraindicated\n* Participation in another investigational trial within 90 days\n* Pregnancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 18 or older",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age 18 or older"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Willing and able to comply with the study procedures and provide written informed consent to participate in the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Willing and able to comply with the study procedures"
                    ],
                    "criterion": "compliance with study procedures",
                    "requirement_type": "willingness and ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "provide written informed consent to participate in the study"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Diagnosis of probable pancreatic cancer"
                    ],
                    "criterion": "pancreatic cancer",
                    "requirement_type": "diagnosis",
                    "expected_value": "probable"
                },
                {
                    "exact_snippets": [
                        "distal common bile duct (CBD) cholangiocarcinoma"
                    ],
                    "criterion": "distal common bile duct cholangiocarcinoma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other periampullary cancers"
                    ],
                    "criterion": "periampullary cancers",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Biliary obstructive symptoms or signs",
            "criterions": [
                {
                    "exact_snippets": [
                        "Biliary obstructive symptoms or signs"
                    ],
                    "criterion": "biliary obstruction",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Bilirubin level at/above 100 umol per liter (5.8 mg/dL)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Bilirubin level",
                        "at/above 100 umol per liter"
                    ],
                    "criterion": "bilirubin level",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Distal biliary obstruction"
                    ],
                    "criterion": "distal biliary obstruction",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "consistent with pancreatic cancer"
                    ],
                    "criterion": "pancreatic cancer",
                    "requirement_type": "consistency",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "distal CBD cholangiocarcinoma"
                    ],
                    "criterion": "distal CBD cholangiocarcinoma",
                    "requirement_type": "consistency",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other periampullary malignancy"
                    ],
                    "criterion": "periampullary malignancy",
                    "requirement_type": "consistency",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum",
            "criterions": [
                {
                    "exact_snippets": [
                        "Location of distal biliary obstruction"
                    ],
                    "criterion": "distal biliary obstruction",
                    "requirement_type": "location",
                    "expected_value": "allow stent positioning"
                },
                {
                    "exact_snippets": [
                        "allow the proximal end of a stent to be positioned at least 2cm from the hilum"
                    ],
                    "criterion": "stent positioning",
                    "requirement_type": "distance from hilum",
                    "expected_value": ">= 2"
                }
            ]
        },
        {
            "line": "* Patients deemed as resectable by pancreatic protocol CT or MRI",
            "criterions": [
                {
                    "exact_snippets": [
                        "resectable"
                    ],
                    "criterion": "resectability",
                    "requirement_type": "status",
                    "expected_value": "resectable"
                },
                {
                    "exact_snippets": [
                        "pancreatic protocol CT or MRI"
                    ],
                    "criterion": "imaging modality",
                    "requirement_type": "type",
                    "expected_value": [
                        "pancreatic protocol CT",
                        "MRI"
                    ]
                }
            ]
        },
        {
            "line": "* Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion",
            "criterions": [
                {
                    "exact_snippets": [
                        "Surgical candidate"
                    ],
                    "criterion": "surgical candidacy",
                    "requirement_type": "status",
                    "expected_value": "candidate"
                },
                {
                    "exact_snippets": [
                        "per pancreatobiliary surgeon"
                    ],
                    "criterion": "pancreatobiliary surgeon",
                    "requirement_type": "approval",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "after multi-disciplinary discussion"
                    ],
                    "criterion": "multi-disciplinary discussion",
                    "requirement_type": "completion",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Surgery intent within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": [
                        "Surgery intent"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "intent",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 4 weeks"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "timeframe",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Endoscopic and surgical treatment to be provided by same team",
            "criterions": [
                {
                    "exact_snippets": [
                        "Endoscopic and surgical treatment to be provided by same team"
                    ],
                    "criterion": "endoscopic and surgical treatment",
                    "requirement_type": "provider",
                    "expected_value": "same team"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Biliary strictures caused by confirmed benign tumors",
            "criterions": [
                {
                    "exact_snippets": [
                        "Biliary strictures"
                    ],
                    "criterion": "biliary strictures",
                    "requirement_type": "cause",
                    "expected_value": "benign tumors"
                },
                {
                    "exact_snippets": [
                        "benign tumors"
                    ],
                    "criterion": "tumors",
                    "requirement_type": "nature",
                    "expected_value": "benign"
                }
            ]
        },
        {
            "line": "* Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers",
            "criterions": [
                {
                    "exact_snippets": [
                        "Biliary strictures caused by malignancies other than pancreatic cancer"
                    ],
                    "criterion": "biliary strictures",
                    "requirement_type": "cause",
                    "expected_value": "malignancies other than pancreatic cancer"
                },
                {
                    "exact_snippets": [
                        "Biliary strictures caused by malignancies other than",
                        "distal CBD cholangiocarcinoma"
                    ],
                    "criterion": "biliary strictures",
                    "requirement_type": "cause",
                    "expected_value": "malignancies other than distal CBD cholangiocarcinoma"
                },
                {
                    "exact_snippets": [
                        "Biliary strictures caused by malignancies other than",
                        "other periampullary cancers"
                    ],
                    "criterion": "biliary strictures",
                    "requirement_type": "cause",
                    "expected_value": "malignancies other than other periampullary cancers"
                }
            ]
        },
        {
            "line": "* Surgically altered biliary tract anatomy, not including prior cholecystectomy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Surgically altered biliary tract anatomy"
                    ],
                    "criterion": "biliary tract anatomy",
                    "requirement_type": "surgical alteration",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "prior cholecystectomy"
                    ],
                    "criterion": "cholecystectomy",
                    "requirement_type": "history",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Neoadjuvant chemotherapy for current malignancy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Neoadjuvant chemotherapy for current malignancy"
                    ],
                    "criterion": "neoadjuvant chemotherapy",
                    "requirement_type": "association",
                    "expected_value": "current malignancy"
                }
            ]
        },
        {
            "line": "* Palliative indication due to reasons other than surgical candidate status",
            "criterions": [
                {
                    "exact_snippets": [
                        "Palliative indication"
                    ],
                    "criterion": "palliative indication",
                    "requirement_type": "reason",
                    "expected_value": "other than surgical candidate status"
                }
            ]
        },
        {
            "line": "* Previous biliary drainage by ERCP/PTC",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous biliary drainage"
                    ],
                    "criterion": "biliary drainage",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ERCP"
                    ],
                    "criterion": "ERCP",
                    "requirement_type": "procedure",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "PTC"
                    ],
                    "criterion": "PTC",
                    "requirement_type": "procedure",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients for whom endoscopic techniques are contraindicated",
            "criterions": [
                {
                    "exact_snippets": [
                        "endoscopic techniques are contraindicated"
                    ],
                    "criterion": "endoscopic techniques",
                    "requirement_type": "contraindication",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Participation in another investigational trial within 90 days",
            "criterions": [
                {
                    "exact_snippets": [
                        "Participation in another investigational trial within 90 days"
                    ],
                    "criterion": "participation in another investigational trial",
                    "requirement_type": "time since last participation",
                    "expected_value": {
                        "operator": ">=",
                        "value": 90
                    }
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}