RecruitingNot ApplicableNCT04364373

D2 vs D3 Lymph Node Dissection for Left Colon Cancer

D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)

Sponsor

Russian Society of Colorectal Surgeons

Enrollment

1,381 participants

Start Date

Mar 31, 2020

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

Summary

The efficiency of the D3 lymph node dissection is still controversial for left colon cancer patients. This study will try find difference in 5-year overall survival between D2 and D3 lymph node dissection. Investigation of the functional and short-term outcomes will clarify safety of the D3 lymph node dissection.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different extents of lymph node removal surgery (D2 vs D3 dissection) in patients with left-sided colon cancer, to determine whether removing more lymph nodes along the main blood vessels improves survival outcomes or increases complications. **You may be eligible if:** - You have confirmed colon cancer (specifically adenocarcinoma — the most common type) - Your tumor is located in the left colon (between the splenic flexure and the rectosigmoid junction) - Your cancer is locally advanced (T3–T4a) without confirmed distant spread (M0) - You are in good enough health to undergo surgery and tolerate chemotherapy (ASA score 1–3) **You may NOT be eligible if:** - Your cancer is at a very early stage (T1–T2) or is growing into adjacent organs (T4b involving pancreas, stomach, ureter, or bladder) - You have emergency complications like perforation or complete bowel obstruction - You have previously received radiation or chemotherapy for this cancer - You have another simultaneous or prior colon cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELeft colon resection

This procedure is performed for tumours in splenic flexure and proximal and descending colon. Left colic artery is divided at its origin. Sigmoid arteries and superior rectal arteries are preserved. Inferior mesenteric vein is divided at the lower border of the pancreas. The colon is divided about 10 cm proximal and distal to the tumour. Mesocolic fascia is preserved and the length of the "vessel trunk" of the mesocolon corresponds to the level of lymph node dissection. After removal of the resected colonic segment a handsewn or stapler end-to-end or side-to-side colonic anastomosis is performed.

PROCEDURESigmoid colon resection

This procedure is performed for tumours in sigmoid colon. Corresponding sigmoid arteries are divided at their origin. Left colic artery and superior rectal artery are preserved. Inferior mesenteric vein is divide close to the left colic artery. Proximal and distal margin compose 10 cm from the tumour. Mesocolic fascia is preserved and the length of the "vessel trunk" of the mesocolon corresponds to the level of lymph nodes dissection. After removal of the resected colonic segment a handsewn end-to-end or side-to-side or stapler colonic anastomosis is performed.

PROCEDUREDistal sigmoid colon resection or anterior resection

This procedure is performed for tumours in distal sigmoid colon or rectosigmoid junction. Superior rectal artery is divided below the origin of left colic artery. Left colic artery is preserved. Inferior mesenteric vein is divide close to the left colic artery. The colon is divided about 10 cm proximal and 5 cm distal to the tumour. Mesocolic fascia is preserved and the length of the "vessel trunk" of the mesocolon corresponds to the level of lymph node dissection. After removal of the resected colonic segment handsewn or stapler colo-rectal anastomosis is performed.

Locations(1)

Clinic of coloproctology and minimally invasive surgery

Moscow, Russia

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NCT04364373

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