Colon Cancer
Conditions
Keywords
D2, D3, lymph node dissection, complete mesocolic excision, left colon cancer, CME
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
Interventions
PROCEDURELeft 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 resected colonic segment a handsewn or stapler end-to-end or side-to-side colonic anastomosis is performed.
PROCEDURESigmoid 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-to-end or side-to-side or stapler colonic anastomosis is performed.
PROCEDUREDistal 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 colonic segment handsewn or stapler colo-rectal anastomosis is performed.
Sponsors
Russian Society of Colorectal Surgeons
I.M. Sechenov First Moscow State Medical University
G.V. Bondar Republican Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 % |
| Intraoperative complications rate | Day 0 | The rate of any complications within the course of surgery |
| Early postoperative complications rate | 1-30 days after surgery | The rate of surgical and infectious complications |
| 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 |
Countries
Russia
Contacts
CONTACTVladimir Balaban, Ph.D
CONTACTInna Tulina, Ph.D
STUDY_DIRECTORPeter Tsarkov, Ph.D
I.M. Sechenov First Moscow State Medical University
Outcome results
None listed