Multicenter Prospective Study Protocol for Validating Surgical Quality Standards in D3 Lymphadenectomy for Oncological Right Hemicolectomy (D3L)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Álvaro García-Granero, MD, PhD
- Telefoonnummer: +34871205000
- E-mail: alvaro.garciagranero@ssib.es
Studie Contact Back-up
- Naam: Sebastian Jeri, MD, PhD
- Telefoonnummer: +34871205000
- E-mail: sebastian.jeri@ssib.es
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients under 18 years of age or lack of informed consent for inclusion in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Complete or Incomplete D3L
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Total Number of Lymph Nodes Retrieved
Tijdsspanne: From enrollment to the end of treatment at 8 weeks"
|
To evaluate the total number of lymph nodes retrieved following D3 lymphadenectomy Unit of Measure: Number of lymph nodes |
From enrollment to the end of treatment at 8 weeks"
|
|
Positive Lymph Nodes Retrieved from the D3 Lymphadenectomy Area
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
|
To determine the presence and number of positive lymph nodes within the D3 lymphadenectomy area. Unit of Measure: Number of positive lymph nodes |
From enrollment to the end of treatment at 8 weeks
|
|
Perioperative Complications
Tijdsspanne: From enrollment to the end of treatment at 30 days.
|
To assess the incidence and severity of perioperative complications following right hemicolectomy with D3 lymphadenectomy, according to the Clavien-Dindo classification. |
From enrollment to the end of treatment at 30 days.
|
|
Local Recurrence
Tijdsspanne: From enrollment to the end of treatment at 5 years
|
To assess the rate of local recurrence following right hemicolectomy with D3 lymphadenectomy. |
From enrollment to the end of treatment at 5 years
|
|
Systemic Recurrence
Tijdsspanne: From enrollment to 5 years
|
To assess the rate of systemic recurrence following right hemicolectomy with D3 lymphadenectomy. |
From enrollment to 5 years
|
|
Three-Year Overall Survival
Tijdsspanne: From enrollment to 3 years
|
To assess overall survival at 3 years following right hemicolectomy with D3 lymphadenectomy. |
From enrollment to 3 years
|
|
Five-Year Overall Survival
Tijdsspanne: From enrollment to 5 years
|
To assess overall survival at 5 years following right hemicolectomy with D3 lymphadenectomy. |
From enrollment to 5 years
|
Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Multicenter_D3L
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
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