NCT07847216

Brief 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). 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
61mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Sep 2031

Study Start

First participant enrolled

September 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

September 23, 2026

Last Update Submit

September 29, 2026

Conditions

Colon NeoplasmsRight Colon TumorsLymphadenectomy

Keywords

Colon neoplasmD3 lymph node excisionOncological outcomesPathology qualityMulticenter study

Outcome Measures

Primary Outcomes (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.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

  • Total Number of Lymph Nodes Retrieved

    From enrollment to the end of treatment at 8 weeks"

  • Positive Lymph Nodes Retrieved from the D3 Lymphadenectomy Area

    From enrollment to the end of treatment at 8 weeks

  • Perioperative Complications

    From enrollment to the end of treatment at 30 days.

  • Local Recurrence

    From enrollment to the end of treatment at 5 years

  • Systemic Recurrence

    From enrollment to 5 years

  • +2 more secondary outcomes

Study Arms (1)

Patients with right colon neoplasm

pPtients 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.

Procedure: Right Colectomy & D3 Lymphadenectomy

Interventions

Right Colectomy & D3 LymphadenectomyPROCEDURE

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.

Patients with right colon neoplasm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 40503608BACKGROUND

  • 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.

    PMID: 33676793BACKGROUND

  • 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.

    PMID: 39162907BACKGROUND

  • 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.

    PMID: 31996584BACKGROUND

  • 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.

    PMID: 26833471BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Right Hemicolectomy with D3 Lymphadenectomy will be retained for microscopic analysis at the Pathology department of each participating center. No changes on usual procedures for this type of pathology are going to be made.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Álvaro García-Granero, MD, PhD

CONTACT

+34871205000alvaro.garciagranero@ssib.es

Sebastian Jeri, MD, PhD

CONTACT

+34871205000sebastian.jeri@ssib.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, PhD

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 29, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2031

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.