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Colon NeoplasmsD3LNCT07847216

Multicenter Prospective Study Protocol for Validating Surgical Quality Standards in D3 Lymphadenectomy for Oncological Right Hemicolectomy

An observational study of Colon Neoplasms and Right Colon Tumors, run by Fundació d'investigació Sanitària de les Illes Balears.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Introduction: D3 lymphadenectomy (D3L) for right hemicolectomy, proposed by Eastern guidelines, aims to improve oncological outcomes by extending resection to include lymphatic drainage zones beyond those addressed by complete mesocolic excision (CME). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Right Colectomy & D3 Lymphadenectomy
Type of treatment
Surgery or procedure
How many people
120 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 30 Sep 2031
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.

Who may be able to join

  • The study includes consecuent patients undergoing either elective or emergency surgery with a diagnosis of adenocarcinoma or adenoma with dysplasia located in the cecum, ascending colon, or hepatic flexure of the colon.

Who cannot join

  • Patients under 18 years of age or lack of informed consent for inclusion in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Álvaro García-Granero, MD, PhD contact

+34871205000

alvaro.garciagranero@ssib.es

Sebastian Jeri, MD, PhD contact

+34871205000

sebastian.jeri@ssib.es

About this study

Introduction: D3 lymphadenectomy (D3L) for right hemicolectomy, proposed by Eastern guidelines, aims to improve oncological outcomes by extending resection to include lymphatic drainage zones beyond those addressed by complete mesocolic excision (CME). However, the absence of standardized anatomopathological quality parameters limits its validation. This multicenter study seeks to validate this criteria, including the "right mesocolic sail," to classify D3L specimens and evaluate its clinical and oncological implications.

Materials and Methods: This prospective, multicenter study involves 11 hospitals in Spain. Surgical specimens from right hemicolectomy with D3L will be analyzed for the presence of the "right mesocolic sail" and classified as complete or incomplete D3L. Standard CME criteria will also be applied. Patient data, surgical details, and oncological outcomes at 3 and 5 years will be collected. Statistical analysis will compare lymph node retrieval, recurrence rates, survival outcomes, and perioperative complications between groups.

Read more

Results: The study will validate the right mesocolic sail as a quality parameter for D3L. Preliminary data from prior phases confirm increased lymph node retrieval and the presence of positive nodes in D3L specimens. Additional analyses will determine the impact of D3L on recurrence rates, survival, and perioperative risks.

Discussion: This study aims to provide standardized anatomopathological criteria to evaluate D3L, facilitating comparative studies and addressing its controversial oncological benefits. If validated, the criteria could enhance surgical quality assessment and inform future guidelines.

Being tested
Right Colectomy & D3 Lymphadenectomy
Keywords
Colon neoplasm, D3 lymph node excision, Oncological outcomes, Pathology quality, Multicenter study
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Right Colectomy & D3 LymphadenectomyProcedure or surgery

    Patients enrolled would receive a right colectomy with dissection of the Lymphoadipose tissue over the superior mesenteric vein, including all the tissue from the ileocolic vessels to the superior right colic vein.

Study groups in NCT07847216
Study groupRoleWhat they receive
Patients with right colon neoplasmpPtients over 18 years of age undergoing either elective or emergency surgery with a diagnosis of adenocarcinoma or adenoma with dysplasia located in the cecum, ascending colon, or hepatic flexure of the colon.
Receives: Procedure: Right Colectomy & D3 Lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete or Incomplete D3L

    Validation of Anatomopathological Criteria for Quality Assessment: to validate, through a multicenter study, the effectiveness of new anatomopathological criteria for right hemicolectomy with D3 lymphadenectomy (D3L) in accurately classifying surgical specimens as complete or incomplete D3L.

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (7)

  1. Total Number of Lymph Nodes Retrieved

    To evaluate the total number of lymph nodes retrieved following D3 lymphadenectomy Unit of Measure: Number of lymph nodes

    Measured: From enrollment to the end of treatment at 8 weeks"

  2. Positive Lymph Nodes Retrieved from the D3 Lymphadenectomy Area

    To determine the presence and number of positive lymph nodes within the D3 lymphadenectomy area.

    Unit of Measure: Number of positive lymph nodes

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Perioperative Complications

    To assess the incidence and severity of perioperative complications following right hemicolectomy with D3 lymphadenectomy, according to the Clavien-Dindo classification.

    Measured: From enrollment to the end of treatment at 30 days.

  4. Local Recurrence

    To assess the rate of local recurrence following right hemicolectomy with D3 lymphadenectomy.

    Measured: From enrollment to the end of treatment at 5 years

  5. Systemic Recurrence

    To assess the rate of systemic recurrence following right hemicolectomy with D3 lymphadenectomy.

    Measured: From enrollment to 5 years

  6. Three-Year Overall Survival

    To assess overall survival at 3 years following right hemicolectomy with D3 lymphadenectomy.

    Measured: From enrollment to 3 years

  7. Five-Year Overall Survival

    To assess overall survival at 5 years following right hemicolectomy with D3 lymphadenectomy.

    Measured: From enrollment to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07847216
Sponsor's protocol ID
Multicenter_D3L
Acronym
D3L
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data (IPD) will be shared because the study was not designed with a data-sharing framework, and the informed consent and ethics approval do not include provisions for public dissemination of participant-level data. To protect participant confidentiality and comply with institutional and regulatory requirements, only aggregated study results will be made available through scientific publications and presentations.

Publications

  • Sica GS, Anania G, Fiorani C, Siragusa L, Vinci D, Caricato M, Delrio P, Agrusa A, Baldazzi G, Reddavid R, Pellino G; RRoC-STAR Collaborative Group. Standardization of the surgical technique and reporting for radical right colectomy with central vascular ligation and complete mesocolic excision (RRoC-STAR): Delphi consensus. BJS Open. 2025 May 7;9(3):zraf066. doi: 10.1093/bjsopen/zraf066.

    PubMed 40503608

  • Balciscueta Z, Balciscueta I, Uribe N, Pellino G, Frasson M, Garcia-Granero E, Garcia-Granero A. D3-lymphadenectomy enhances oncological clearance in patients with right colon cancer. Results of a meta-analysis. Eur J Surg Oncol. 2021 Jul;47(7):1541-1551. doi: 10.1016/j.ejso.2021.02.020. Epub 2021 Feb 26.

    PubMed 33676793

  • Garcia-Granero A, Gil-Catalan A, Jeri-McFarlane S, Sancho-Muriel J, Pellino G, Gamundi-Cuesta M, Garcia-Granero E, Gonzalez-Argente FX. Proposal for standardization of laparoscopic D3 lymphadenectomy for right colon cancer. Tech Coloproctol. 2024 Aug 20;28(1):111. doi: 10.1007/s10151-024-02974-8.

    PubMed 39162907

  • Garcia-Granero A, Pellino G, Giner F, Frasson M, Grifo Albalat I, Sanchez-Guillen L, Valverde-Navarro AA, Garcia-Granero E. A Proposal for Novel Standards of Histopathology Reporting for D3 Lymphadenectomy in Right Colon Cancer: The Mesocolic Sail and Superior Right Colic Vein Landmarks. Dis Colon Rectum. 2020 Apr;63(4):450-460. doi: 10.1097/DCR.0000000000001589.

    PubMed 31996584

  • Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.

    PubMed 26833471

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Neoplasms and Right Colon Tumors, run by Fundació d'investigació Sanitària de les Illes Balears.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Álvaro García-Granero, MD, PhD (+34871205000, alvaro.garciagranero@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete or Incomplete D3L (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07847216, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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