D2 vs D3 Lymph Node Dissection for Left Colon Cancer

Last updated: April 8, 2024
Sponsor: Russian Society of Colorectal Surgeons
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Treatment

Left colon resection

Distal sigmoid colon resection or anterior resection

Sigmoid colon resection

Clinical Study ID

NCT04364373
0002
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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

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

Study Design

Total Participants: 1381
Treatment Group(s): 3
Primary Treatment: Left colon resection
Phase:
Study Start date:
March 31, 2020
Estimated Completion Date:
December 31, 2033

Study Description

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

Connect with a study center

  • Clinic of coloproctology and minimally invasive surgery

    Moscow, 119435
    Russian Federation

    Active - Recruiting

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