Clinico-oncological Safety and Efficacy of Real-time Fluorescence Lymph Node Mapping (FLNM) in Laparoscopic and Robotic Right Hemicolectomy for Patients with Locally Advanced Right-sided Colon Cancer; Multicenter Phase II Open labelled Randomized Controlled Trial (CONSTELLARE study)

Pusan National University Yangsan Hospital0 个研究点目标入组 186 人开始时间: 待定最近更新: 2024年7月23日

适应症

试验速览

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•1. Patients who over 19 years old, Under 85 years old
•2. Patient with locally advanced right colon cancer requiring D3 lymphadenectomy
•3. Colon cancer patients diagnosed with clinical stage cT3-4 N0 or cTany N1-2 before surgery
•4. Patient with right-sided colon cancer located in the cecum, ascending colon, flexure colon, and proximal transverse colon.
•5. Patients with American Society of Anesthesiology (ASA) I-III
•6. Patients who agreed to the research purpose and voluntarily gave informed consent

•1. Patients with a history of allergy or side effects to sodium iodine
•2. Patients with colon cancer who have distant or peritoneal metastases
•3. Patients requiring emergency surgery due to colon obstruction or colon perforation
•4. Patients with inflammatory bowel disease not controlled by drug treatment
•5. Patients with concurrent cancer in other areas other than colon cancer
•6. Patients with a history of hereditary disease or coagulopathy at risk of bleeding
•7. Women who are pregnant or may be pregnant and lactating women
•8. Patients with chronic renal failure (e-GFR < 15) or patients receiving dialysis at the time of screening
•9. Patients diagnosed with liver failure or with decreased consciousness due to hepatic encephalopathy
•10. Patients judged to have difficulty in smooth lymph perfusion due to heart disease (acute myocardial infarction, acute and chronic heart failure) within the past 6 months
•11. Patients unable to undergo general anesthesia
•12. Patients with American Society of Anesthesiology (ASA) IV or V
•13. Patients who do not wish to participate in this study
•14. Patients who are judged by the researcher to be unsuitable for participation in this clinical trial
•(Example: People with a life expectancy of less than 6 months, people expected to have low compliance with clinical trials, etc.)

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