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.
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.
Patients under 18 years of age or lack of informed consent for inclusion in the study.
Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.
Cohort
Prospective
Right Colectomy & D3 Lymphadenectomy
Procedure/SurgeryPatients 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.
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.
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
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
Perioperative Complications
To assess the incidence and severity of perioperative complications following right hemicolectomy with D3 lymphadenectomy, according to the Clavien-Dindo classification.
Local Recurrence
To assess the rate of local recurrence following right hemicolectomy with D3 lymphadenectomy.
Click on the lead sponsor to view all of their trials.
Fundació d'investigació Sanitària de les Illes Balears
Lead sponsor
Hospital Universitari de Bellvitge
Collaborator
Hospital Universitario La Fe
Collaborator
Hospital Universitario Marqués de Valdecilla
Collaborator
Hospital Universitari Vall d'Hebron Research Institute
Collaborator
Hospital General Universitario Gregorio Marañon
Collaborator
Hospital Universitario Ramon y Cajal
Collaborator
University Hospital of Girona Dr. Josep Trueta
Collaborator
Hospital General Universitario Reina Sofía de Murcia
Collaborator
Hospital del Mar
Collaborator
Hospital Son Espases
Collaborator
Hospital Álvaro Cunqueiro
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
