None listed
Conditions
Interventions
Drug, Procedure/Surgery : When a participant voluntarily agrees to take part in a clinical trial, they are assigned a screening number in the sequence in which their consent is received. Participation
Sponsors
Pusan National University Yangsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological D3 lymph node metastasis detection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Harvest lymph nodes (Total lymph nodes, lymph nodes near tumor, D3 lymph nodes, ICA/RCA/MCA lymph nodes);lymph node ratio;Clinicopathological factors associated with FLNM success rate (Gender, age, BMI, pathological stage, tumor size, colon obstruction, etc.);The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery;Surgical quality (Measurement of mesenteric dissection surface quality, proximal and distal resection lengths);Estimated Blood loss(ml), Operation time(min) ;Complications, readmission, and reoperation within 30 days after surgery;Assessment of completeness of D3 lymph node dissection;3year disease-free survival rate, overall survival rate, local and systemic recurrence rate;Satisfaction survey on FLNM-guided D3 lymphadenectomy | — |
Countries
Korea, Republic of
Contacts
Public ContactIN YOUNG LEE
Pusan National University Yangsan Hospital
Outcome results
None listed