{
"info": {
"nct_id": "NCT03273920",
"official_title": "Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial",
"inclusion_criteria": "1. Pathologically proven gastric adenocarcinoma.\n2. Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.\n3. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. American Society of Anesthesiology (ASA) score of class I to III\n6. Patients who freely give informed consent to participate in the clinical study\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)\n2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)\n3. Gastric cancer-related complications (complete obstruction or perforation)\n4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging\n5. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer\n6. Patients diagnosed with other malignancy within 5 years\n7. Severe mental disorder\n8. Unstable angina or myocardial infarction within the past 6 months\n9. Cerebrovascular accident within the past 6 months\n10. Severe respiratory disease (FEV1< 50%)\n11. Continuous systemic steroid therapy within 1 month before the study\n12. Pregnant or breast-feeding women",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Pathologically proven gastric adenocarcinoma.",
"criterions": [
{
"exact_snippets": "Pathologically proven gastric adenocarcinoma",
"criterion": "gastric adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically proven"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pathologically proven gastric adenocarcinoma",
"criterion": "gastric adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically proven"
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Tumor located in the lower third of the stomach",
"criterion": "tumor location",
"requirement": {
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"expected_value": "lower third of the stomach"
}
},
{
"exact_snippets": "possible to be curatively resected by subtotal gastrectomy",
"criterion": "tumor resectability",
"requirement": {
"requirement_type": "resectability",
"expected_value": "curatively resected by subtotal gastrectomy"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Tumor located in the lower third of the stomach",
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}
},
{
"exact_snippets": "possible to be curatively resected by subtotal gastrectomy",
"criterion": "tumor resectability",
"requirement": {
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"expected_value": "curatively resected by subtotal gastrectomy"
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
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"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "T"
},
{
"operator": "<=",
"value": 4,
"unit": "T"
}
]
}
}
},
{
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"criterion": "cN stage",
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{
"operator": ">=",
"value": 0,
"unit": "N"
},
{
"operator": "<=",
"value": 3,
"unit": "N"
}
]
}
}
},
{
"exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
"criterion": "cM stage",
"requirement": {
"requirement_type": "equality",
"expected_value": {
"operator": "=",
"value": 0,
"unit": "M"
}
}
},
{
"exact_snippets": "according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition",
"criterion": "staging system edition",
"requirement": {
"requirement_type": "edition",
"expected_value": "American Joint Committee on Cancer/Union for International Cancer Control 8th edition"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
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{
"operator": ">=",
"value": 2,
"unit": "T"
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"unit": "T"
}
]
}
}
},
{
"exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
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"operator": ">=",
"value": 0,
"unit": "N"
},
{
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"unit": "N"
}
]
}
}
},
{
"exact_snippets": "Preoperative stage of cT2-4aN0-3M0",
"criterion": "cM stage",
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"expected_value": {
"operator": "=",
"value": 0,
"unit": "M"
}
}
}
]
},
{
"exact_snippets": "according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition",
"criterion": "staging system edition",
"requirement": {
"requirement_type": "edition",
"expected_value": "American Joint Committee on Cancer/Union for International Cancer Control 8th edition"
}
}
]
}
},
{
"identified_line": {
"line": "4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
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{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
}
},
{
"identified_line": {
"line": "5. American Society of Anesthesiology (ASA) score of class I to III",
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{
"exact_snippets": "American Society of Anesthesiology (ASA) score of class I to III",
"criterion": "ASA score",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "class"
},
{
"operator": "<=",
"value": 3,
"unit": "class"
}
]
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "American Society of Anesthesiology (ASA) score of class I to III",
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"requirement": {
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{
"operator": ">=",
"value": 1,
"unit": "class"
},
{
"operator": "<=",
"value": 3,
"unit": "class"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "6. Patients who freely give informed consent to participate in the clinical study",
"criterions": [
{
"exact_snippets": "Patients who freely give informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Patients who freely give informed consent",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirement": {
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"value": 20,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
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{
"exact_snippets": "maximum age of 75 Years",
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"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
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"line": "1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)",
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"exact_snippets": "Previous upper abdominal surgery",
"criterion": "previous upper abdominal surgery",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "except laparoscopic cholecystectomy",
"criterion": "laparoscopic cholecystectomy",
"requirement": {
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"expected_value": true
}
}
]
},
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"criterion": "previous upper abdominal surgery",
"requirement": {
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"expected_value": true
}
},
"then_criteria": {
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"exact_snippets": "except laparoscopic cholecystectomy",
"criterion": "laparoscopic cholecystectomy",
"requirement": {
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"expected_value": true
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "2. Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)",
"criterions": [
{
"exact_snippets": "Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)",
"criterion": "previous gastric resection",
"requirement": {
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"expected_value": true
}
}
]
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"expected_value": true
}
}
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging",
"criterion": "regional lymph node",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "cm"
}
}
}
]
},
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{
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"operator": ">",
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}
]
}
},
{
"identified_line": {
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"exact_snippets": "Previous neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Previous ... radiotherapy for gastric cancer",
"criterion": "radiotherapy for gastric cancer",
"requirement": {
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"expected_value": true
}
}
]
},
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}
},
{
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
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"expected_value": true
}
},
{
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"criterion": "other malignancy",
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"unit": "years"
}
]
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}
},
{
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"unit": "years"
}
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}
},
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{
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}
}
]
},
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{
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}
}
]
}
},
{
"identified_line": {
"line": "9. Cerebrovascular accident within the past 6 months",
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{
"exact_snippets": "Cerebrovascular accident within the past 6 months",
"criterion": "cerebrovascular accident",
"requirement": {
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"expected_value": {
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{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
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"value": 6,
"unit": "months"
}
]
}
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Severe respiratory disease",
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}
},
{
"exact_snippets": "FEV1< 50%",
"criterion": "FEV1",
"requirement": {
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"unit": "%"
}
}
}
]
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}
},
{
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"unit": "%"
}
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}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Continuous systemic steroid therapy within 1 month before the study",
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"requirement": {
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"expected_value": "within 1 month before the study"
}
},
{
"exact_snippets": "Continuous systemic steroid therapy within 1 month before the study",
"criterion": "systemic steroid therapy",
"requirement": {
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"expected_value": true
}
}
]
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}
},
{
"exact_snippets": "Continuous systemic steroid therapy within 1 month before the study",
"criterion": "systemic steroid therapy",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "12. Pregnant or breast-feeding women",
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{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast-feeding",
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"requirement": {
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}
}
]
},
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"criterion": "pregnancy",
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"expected_value": false
}
},
{
"exact_snippets": "breast-feeding",
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"requirement": {
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
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{
"exact_snippets": "Gastric cancer-related complications (complete obstruction or perforation)",
"criterion": "gastric cancer-related complications",
"requirement": {
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"perforation"
]
}
}
]
},
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{
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}
},
{
"exact_snippets": "Gastric cancer-related complications (complete obstruction or perforation)",
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"requirement": {
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}
}
]
}
]
}
},
{
"identified_line": {
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{
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"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
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"criterion": "unstable angina",
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"expected_value": true
}
},
{
"exact_snippets": "myocardial infarction within the past 6 months",
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"value": 6,
"unit": "months"
}
}
}
]
}
}
],
"failed_miscellaneous": []
}