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NCT Number: NCT04364373

D2 vs D3 Lymph Node Dissection for Left Colon Cancer

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Left colon resection

Procedure

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.

Sigmoid colon resection

Procedure

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.

Distal sigmoid colon resection or anterior resection

Procedure

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.

Primary outcomes

  1. 5-year overall survival

    Time frame: Up to 5 years post-operatively

    Probability to be alive measured in %, where 100% means that patients have a 100% probability to be alive and 0% means that patients have 0% probability to be alive

Secondary outcomes

  1. 5-year disease free survival

    Time frame: Up to 5 years post-operatively

    Probability to be alive with no signs of local or distant recurrence measured in %, where 100% means that patients have a 100% probability to be alive with no signs of local or distant recurrence and 0% means that patients have 0% probability to be alive with no signs of local or distant recurrence

  2. Postoperative sexual dysfunction

    Time frame: Up to 1 year post-operatively

    The rate of ejaculation problems in sexually active men and the rate of decreased vaginal lubricant production in sexually active women, measured in % from the total number of male/female patients

  3. Apical lymph node involvement rate

    Time frame: 1 month after surgery

    The rate of lymph nodes 253 with metastatic cells among all lymph nodes 253, measured in %

  4. Intraoperative complications rate

    Time frame: Day 0

    The rate of any complications within the course of surgery

  5. Early postoperative complications rate

    Time frame: 1-30 days after surgery

    The rate of surgical and infectious complications

  6. Mortality

    Time frame: 0-30 days after surgery

    The rate of death from all causes

  7. Late postoperative complications rate

    Time frame: 30-180 days after surgery

    The rate of surgical and infectious complications

Study contacts

Contact information is provided by the study sponsor or research team.

Inna Tulina, Ph.D

CONTACT

[email protected]

+79264086672

Vladimir Balaban, Ph.D

CONTACT

[email protected]

+79889478358

Sponsors and collaborators

Lead sponsor

Russian Society of Colorectal Surgeons

Other

Collaborators

  • G.V. Bondar Republican Cancer Center
  • I.M. Sechenov First Moscow State Medical University

Registry information

Official study title

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

Acronym: DILEMMA

Important dates

Study start
2020
Primary completion
2028
Study completion
2033
First posted
Apr 28, 2020
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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