跳至主要内容
临床试验/NCT07847216
NCT07847216尚未招募不适用

Multicenter Prospective Study Protocol for Validating Surgical Quality Standards in D3 Lymphadenectomy for Oncological Right Hemicolectomy

Fundació d'investigació Sanitària de les Illes Balears0 个研究点目标入组 120 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Complete or Incomplete D3L

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Patients under 18 years of age or lack of informed consent for inclusion in the study.

研究组 & 干预措施

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.

干预措施: Right Colectomy & D3 Lymphadenectomy (Procedure)

结局指标

主要结局

Complete or Incomplete D3L

时间窗: 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.

次要结局

  • Oncological Outcomes(From enrollment to the end of treatment at 5 years)
  • Lymph Node Retrieval(From enrollment to the end of treatment at 8 weeks")
  • Perioperative Risk Assessment(From enrollment to the end of treatment at 30 days.)

研究者

发起方
Fundació d'investigació Sanitària de les Illes Balears
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sebastian Jeri

MD, MSc, PhD

Fundació d'investigació Sanitària de les Illes Balears

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