ClinicalTrials.gg
RecruitingNCT04364373DILEMMAUpdated Aug 17, 2026

D2 vs D3 Lymph Node Dissection for Left Colon Cancer

An interventional study of Left colon resection and Sigmoid colon resection in Colon Cancer, sponsored by Russian Society of Colorectal Surgeons. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Russian Society of Colorectal Surgeons · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,381
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Colonic Neoplasms with a site in Russia — 4 open to participants now, 7 under way, 3 of them phase 3. Colonic Neoplasms · Russia.

Started
2020
with 1 other
No phase
2 of 11
1 open now
Registered
3rd of 11
by date
Lead sponsor
2 of 11
Russian Society of Colorectal Surgeons

Among the 11 studies in Colonic Neoplasms with a site in Russia, this one is one of 2 that started in 2020, is one of 2 with no phase, and was the 3rd registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Observational5 · 0 open
Phase 33 · 2 open
No phasethis study2 · 1 open
Phase 21 · 1 open

By the year they started

First in 2013; this study’s year is marked. 2 started in 2020.

Size and results

Median enrollment 669 across the 6 interventional studies, 700 across the 5 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Colonic Neoplasms with a site in Russia, or all of them as a file.
02

Study 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.

Read the 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

03

Conditions studied

  • Colon Cancer

Browse trials for

Keywords

  • D2
  • D3
  • lymph node dissection
  • complete mesocolic excision
  • left colon cancer
  • CME
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,381 participants (estimated)

Study arms

  • Active comparator
    D2 lymph node dissection

    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

  • Experimental
    D3 lymph node dissection

    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

  • 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.

06

What researchers measure

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

  5. Early postoperative complications rate

    The rate of surgical and infectious complications

    Time frame: 1-30 days after surgery

  6. Mortality

    The rate of death from all causes

    Time frame: 0-30 days after surgery

  7. Late postoperative complications rate

    The rate of surgical and infectious complications

    Time frame: 30-180 days after surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2020 (actual). Primary completion is estimated for Dec 2028, 105 months after the start.

Of 382 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's planned 105 months is above that.

Counting every sponsor, half of 404 studies reached it within 30 months; a quarter within 16 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2020
First posted
Apr 28, 2020
StartActual
Mar 31, 2020
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2033
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04364373
Lead sponsor
Russian Society of Colorectal Surgeons
Collaborators
I.M. Sechenov First Moscow State Medical University, G.V. Bondar Republican Cancer Center
Responsible party
Sponsor
First posted
Apr 28, 2020
Start date
Mar 31, 2020
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Aug 17, 2026

Study contacts

Vladimir Balaban, Ph.D
Contact
balaban@kkmx.ru
+79889478358
Inna Tulina, Ph.D
Contact
tulina@kkmx.ru
+79264086672
Peter Tsarkov, Ph.D
study director · I.M. Sechenov First Moscow State Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion