D2 vs D3 Lymph Node Dissection for Left Colon Cancer

Not Applicable

Recruiting

• Conditions: Colon Cancer
• Interventions: Procedure: Left colon resection; Procedure: Sigmoid colon resection; Procedure: Distal sigmoid colon resection or anterior resection

• Registration Number: NCT04364373
• Lead Sponsor: Russian Society of Colorectal Surgeons

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

Study Timeline

• Study Start: 2020-03-31
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2028-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1381

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D2 lymph node dissection	Sigmoid colon resection	For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed. For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed. For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed. For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
D3 lymph node dissection	Sigmoid colon resection	For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed. For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed. For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed. For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.
D2 lymph node dissection	Left colon resection	For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed. For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed. For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed. For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
D2 lymph node dissection	Distal sigmoid colon resection or anterior resection	For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232 and 231 will be removed. For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and partially 241, 242 (considering variation of the feeding artery) will be removed. For tumours in the mid part of sigmoid colon lymph nodes 241, 242 will be removed. For tumours in the rectosigmoid junction 251, 252 groups of the lymph node will be removed.
D3 lymph node dissection	Distal sigmoid colon resection or anterior resection	For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed. For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed. For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed. For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.
D3 lymph node dissection	Left colon resection	For tumours in splenic flexure and proximal and mid part of descending colon lymph nodes 232, 231 and 253 will be removed. For tumours in distal part of descending colon and proximal sigmoid lymph nodes 231, 232 and 253 and partially 241, 242 (considering variation of the feeding artery) will be removed. For tumours in the mid part of sigmoid colon lymph nodes 241, 242 and 253 will be removed. For tumours in the rectosigmoid junction 251, 252 and 253 groups of the lymph node will be removed.

Primary Outcome Measures

Name	Time	Method
5-year overall survival	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 Outcome Measures

Name	Time	Method
Early postoperative complications rate	1-30 days after surgery	The rate of surgical and infectious complications
Intraoperative complications rate	Day 0	The rate of any complications within the course of surgery
Postoperative sexual dysfunction	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
Apical lymph node involvement rate	1 month after surgery	The rate of lymph nodes 253 with metastatic cells among all lymph nodes 253, measured in %
Mortality	0-30 days after surgery	The rate of death from all causes
Late postoperative complications rate	30-180 days after surgery	The rate of surgical and infectious complications
5-year disease free survival	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

Trial Locations

Locations (1)

Clinic of coloproctology and minimally invasive surgery; 🇷🇺 Moscow, Russian Federation