{
"info": {
"nct_id": "NCT02969148",
"official_title": "Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial",
"inclusion_criteria": "1. The age limits is 18-80 years old;\n2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.\n3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;\n4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;\n5. Criteria of performance status karnofsky is greater than or equal to 60.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. The patients' age limits is Less than 18 years old, or more than 80 years old;\n2. The preoperative imaging confirmed that the tumor involve adjacent organs;\n3. The tumor have been finding distant metastases;\n4. American Society of anesthesiologists (ASA) score more than 3;\n5. Criteria of performance status karnofsky is lower than 60;\n6. There is a laparoscopic surgery contraindications.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. The age limits is 18-80 years old;",
"criterions": [
{
"exact_snippets": "age limits is 18-80 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.",
"criterions": [
{
"exact_snippets": "T3-T4 resectable gastric carcinoma",
"criterion": "gastric carcinoma",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"T3",
"T4"
]
},
{
"requirement_type": "resectability",
"expected_value": true
}
]
},
{
"exact_snippets": "confirmed by CT and pathology",
"criterion": "gastric carcinoma confirmation",
"requirements": [
{
"requirement_type": "methods",
"expected_value": [
"CT",
"pathology"
]
}
]
}
]
},
{
"line": "3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;",
"criterions": [
{
"exact_snippets": "tumor did not involve adjacent organs",
"criterion": "tumor involvement with adjacent organs",
"requirements": [
{
"requirement_type": "involvement",
"expected_value": false
}
]
}
]
},
{
"line": "4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;",
"criterions": [
{
"exact_snippets": "American Society of anesthesiologists (ASA) score less than or equal to Level 3",
"criterion": "ASA score",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "Level"
}
}
]
}
]
},
{
"line": "5. Criteria of performance status karnofsky is greater than or equal to 60.",
"criterions": [
{
"exact_snippets": "performance status karnofsky is greater than or equal to 60",
"criterion": "performance status karnofsky",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
]
}
]
},
{
"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 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. The patients' age limits is Less than 18 years old, or more than 80 years old;",
"criterions": [
{
"exact_snippets": "patients' age limits is Less than 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "patients' age limits is ... more than 80 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 80,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "2. The preoperative imaging confirmed that the tumor involve adjacent organs;",
"criterions": [
{
"exact_snippets": "preoperative imaging confirmed that the tumor involve adjacent organs",
"criterion": "tumor involvement of adjacent organs",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
}
]
},
{
"line": "3. The tumor have been finding distant metastases;",
"criterions": [
{
"exact_snippets": "tumor have been finding distant metastases",
"criterion": "distant metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "4. American Society of anesthesiologists (ASA) score more than 3;",
"criterions": [
{
"exact_snippets": "American Society of anesthesiologists (ASA) score more than 3",
"criterion": "ASA score",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "5. Criteria of performance status karnofsky is lower than 60;",
"criterions": [
{
"exact_snippets": "performance status karnofsky is lower than 60",
"criterion": "performance status (Karnofsky)",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "6. There is a laparoscopic surgery contraindications.",
"criterions": [
{
"exact_snippets": "laparoscopic surgery contraindications",
"criterion": "laparoscopic surgery",
"requirements": [
{
"requirement_type": "contraindications",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}