D2 vs D3 Lymph Node Dissection for Left Colon Cancer

NCT04364373 | Recruiting DMC

• 1 other identifier: 0002
• Study Type: interventional
• Target: 1,381
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

D2; D3; lymph node dissection; complete mesocolic excision; left colon cancer; CME

Outcome Measures

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

  Up to 5 years post-operatively

Secondary Outcomes (7)

• 5-year disease free survival

  Up to 5 years post-operatively

• Postoperative sexual dysfunction

  Up to 1 year post-operatively

• Apical lymph node involvement rate

  1 month after surgery

• Intraoperative complications rate

  Day 0

• Early postoperative complications rate

  1-30 days after surgery

Study Arms (2)

D2 lymph node dissection

ACTIVE COMPARATOR

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.

Procedure: Left colon resection; Procedure: Sigmoid colon resection; Procedure: Distal sigmoid colon resection or anterior resection

D3 lymph node dissection

EXPERIMENTAL

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.

Procedure: Left colon resection; Procedure: Sigmoid colon resection; Procedure: Distal sigmoid colon resection or anterior resection

Interventions

Left colon resection PROCEDURE

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.

D2 lymph node dissection; D3 lymph node dissection

Sigmoid colon resection PROCEDURE

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.

D2 lymph node dissection; D3 lymph node dissection

Distal sigmoid colon resection or anterior resection PROCEDURE

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.

D2 lymph node dissection; D3 lymph node dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Russian Society of Colorectal Surgeons: lead
• I.M. Sechenov First Moscow State Medical University: collaborator
• G.V. Bondar Republican Cancer Center: collaborator

Study Sites (1)

Clinic of coloproctology and minimally invasive surgery

Moscow, 119435, Russia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Peter Tsarkov, Ph.D

  I.M. Sechenov First Moscow State Medical University

  STUDY DIRECTOR

Central Study Contacts

Vladimir Balaban, Ph.D

CONTACT

+79889478358; balaban@kkmx.ru

Inna Tulina, Ph.D

CONTACT

+79264086672; tulina@kkmx.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 28, 2020
• Study Start: March 31, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)