An observational study in Colon Neoplasms, Right Colon Tumors and Lymphadenectomy, sponsored by Fundació d'investigació Sanitària de les Illes Balears. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Fundació d'investigació Sanitària de les Illes Balears · Observational
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.
Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.
Exclusion Criteria:
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
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.
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Lymph Node Retrieval
To evaluate the increase in the number of lymph nodes retrieved following D3L.To confirm the presence of positive lymph nodes within the D3 lymphadenectomy area.
Time frame: From enrollment to the end of treatment at 8 weeks"
Perioperative Risk Assessment
To assess whether performing right hemicolectomy with D3L increases perioperative complications.
Time frame: From enrollment to the end of treatment at 30 days.
Oncological Outcomes
To examine the potential oncological benefits of D3L, including: Local recurrence rates, Systemic recurrence rates and Three- and five-year survival rates.
Time frame: From enrollment to the end of treatment at 5 years
No study locations are listed for this record.
Plan to share: 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.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fundació d'investigació Sanitària de les Illes Balears