D2 vs D3 Lymph Node Dissection for Left Colon Cancer

Официальное название

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

Обзор

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.

Подробное описание

Discussion about optimal type of lymph node dissection in colorectal cancer continues during last 15 years, when in Europe was presented concept of complete mesocolic excision. However, this concepts is very close to Japanese D3 lymph node dissection and in the first view it seems the same but principal differences were found. Japanese concept is partial resection of the bowel according feeding artery (short bowel specimen, long lymphovascular pedicle), opposite European concept is wide resection of the bowel like hemicolectomy or extended hemicolectomy, sigmoidectomy. In complete mesocolic excision anatomical landmarks are still unclear but in Japanese guidelines it has anatomical margins which can standardize this procedure. Also nerve sparing technique around root of inferior mesenteric artery was described. One more difference is in histological examination of the specimen. European concept is to pay more attention to the quality of complete mesocolic excision and less - to the number of investigated lymph nodes. In Japan lymph node extraction is performed by surgical team from the fresh specimen and send to pathologist separately (each group of lymph nodes). Considering the absence of randomized control trials for patients with left colon cancer DILEMMA trial was started using Japanese approach

Вмешательства

• Процедура Left 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 res
• Процедура Sigmoid 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-
• Процедура Distal 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

Первичные конечные точки

• 5-year overall survival [Срок оценки: Up to 5 years post-operatively]

Вторичные конечные точки (7)

• 5-year disease free survival [Срок оценки: Up to 5 years post-operatively]
• Postoperative sexual dysfunction [Срок оценки: Up to 1 year post-operatively]
• Apical lymph node involvement rate [Срок оценки: 1 month after surgery]
• Intraoperative complications rate [Срок оценки: Day 0]
• Early postoperative complications rate [Срок оценки: 1-30 days after surgery]
• Mortality [Срок оценки: 0-30 days after surgery]
• Late postoperative complications rate [Срок оценки: 30-180 days after surgery]

Критерии участия

Критерии включения

• Agreement of the patient to participate in trial
• Colon cancer (only adenocarcinoma )
• The tumor located between the splenic flexure and rectosigmoid junction
• cT3-Т4а,b
• cN0-2
• cM0
• Tolerance of chemotherapy
• ASA 1-3

Критерии исключения

• сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder)
• Preoperative complications of the tumor (perforation and full bowel 3. obstruction)
• Previous radiotherapy or chemotherapy
• Synchronous or metachronous tumors
• Women during Pregnancy or breast feeding period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Clinic of coloproctology and minimally invasive surgery — Moscow

Идентификаторы

NCT: NCT04364373 · 0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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