D2 vs D3 Lymph Node Dissection for Left Colon Cancer
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Left colon resection, Sigmoid colon resection, Distal sigmoid colon resection or anterior resection.
- Who it may be relevant to
- Registry conditions: Colon Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
D2 vs D3 Lymph Node Dissection for Left Colon Cancer: Multicenter Randomize Control Trial (DILEMMA)
Overview
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
- Procedure Left 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 res - Procedure Sigmoid 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- - Procedure Distal 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
Primary outcome measures
- 5-year overall survival [Time frame: Up to 5 years post-operatively]
Secondary outcome measures (7)
- 5-year disease free survival [Time frame: Up to 5 years post-operatively]
- Postoperative sexual dysfunction [Time frame: Up to 1 year post-operatively]
- Apical lymph node involvement rate [Time frame: 1 month after surgery]
- Intraoperative complications rate [Time frame: Day 0]
- Early postoperative complications rate [Time frame: 1-30 days after surgery]
- Mortality [Time frame: 0-30 days after surgery]
- Late postoperative complications rate [Time frame: 30-180 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Clinic of coloproctology and minimally invasive surgery — Moscow
Identifiers
NCT: NCT04364373 · 0002