Comparing D2 and D3 lymph node dissection for left colon cancer
D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)
This study tests whether a new surgical technique for removing lymph nodes during left colon cancer surgery can help patients live longer and have better outcomes compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1381 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Russian Society of Colorectal Surgeons Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04364373 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in 5-year overall survival rates between D2 and D3 lymph node dissection techniques in patients with left colon cancer. It aims to clarify the safety and functional outcomes associated with the D3 lymph node dissection approach, which is based on Japanese surgical guidelines. The trial will involve patients undergoing various types of left colon resections, with a focus on the quality of lymph node extraction and the anatomical precision of the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with adenocarcinoma of the colon located between the splenic flexure and rectosigmoid junction, who meet specific clinical criteria.
Not a fit: Patients with early-stage tumors, preoperative complications, or those who have received prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with left colon cancer.
How similar studies have performed: While the concept of lymph node dissection has been explored, this specific comparison of D2 vs D3 techniques in left colon cancer is novel and has not been extensively tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Agreement of the patient to participate in trial 2. Colon cancer (only adenocarcinoma ) 3. The tumor located between the splenic flexure and rectosigmoid junction 4. cT3-Т4а,b 5. cN0-2 6. cM0 7. Tolerance of chemotherapy 8. ASA 1-3 Exclusion Criteria: 1. сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder) 2. Preoperative complications of the tumor (perforation and full bowel 3. obstruction) 3. Previous radiotherapy or chemotherapy 4. Synchronous or metachronous tumors 5. Women during Pregnancy or breast feeding period
Where this trial is running
Moscow
- Clinic of coloproctology and minimally invasive surgery — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Vladimir Balaban, Ph.D
- Email: balaban@kkmx.ru
- Phone: +79889478358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.