Health Trials

D2 vs D3 Lymph Node Dissection for Left Colon Cancer

ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRussian Society of Colorectal Surgeons

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Left colon resection

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

1,381 Participants
are divided into 2 treatment groups
Group A: D2 lymph node dissectionActive comparator 3 interventions
Group B: D3 lymph node dissectionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

5-year overall survival

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

Time frame
Up to 5 years post-operatively

Secondary outcomes

1

5-year disease free survival

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

Time frame
Up to 5 years post-operatively
2

Postoperative sexual dysfunction

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

Time frame
Up to 1 year post-operatively
3

Apical lymph node involvement rate

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

Time frame
1 month after surgery
4

Intraoperative complications rate

The rate of any complications within the course of surgery

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Russian Society of Colorectal Surgeons

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Collaborator

G.V. Bondar Republican Cancer Center

Collaborator

Source ClinicalTrials.gov
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