Clinical trial NCT04364373: D2 vs D3 Lymph Node Dissection for Left Colon Cancer
Official title: D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: D2
D3
lymph node dissection
complete mesocolic excision
left colon cancer
CME
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
Collaborators: name: I.M. Sechenov First Moscow State Medical University
name: G.V. Bondar Republican Cancer Center
First posted: 2020-04-28
Enrollment: 1381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: 5-year overall survival
timeFrame: Up to 5 years post-operatively
Secondary outcomes:
measure: 5-year disease free survival
timeFrame: Up to 5 years post-operatively
measure: Postoperative sexual dysfunction
timeFrame: Up to 1 year post-operatively
measure: Apical lymph node involvement rate
timeFrame: 1 month after surgery
measure: Intraoperative complications rate
timeFrame: Day 0
measure: Early postoperative complications rate
timeFrame: 1-30 days after surgery
measure: Mortality
timeFrame: 0-30 days after surgery
measure: Late postoperative complications rate
timeFrame: 30-180 days after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of coloproctology and minimally invasive surgery
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Peter Tsarkov, Ph.D
role: STUDY_DIRECTOR
References: