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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Álvaro García-Granero, MD, PhD
- Número de teléfono: +34871205000
- Correo electrónico: alvaro.garciagranero@ssib.es
Copia de seguridad de contactos de estudio
- Nombre: Sebastian Jeri, MD, PhD
- Número de teléfono: +34871205000
- Correo electrónico: sebastian.jeri@ssib.es
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Complete or Incomplete D3L
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Number of Lymph Nodes Retrieved
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From enrollment to 5 years
|
To assess overall survival at 5 years following right hemicolectomy with D3 lymphadenectomy. |
From enrollment to 5 years
|
Colaboradores e Investigadores
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Multicenter_D3L
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
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