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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Álvaro García-Granero, MD, PhD
- 電話番号：+34871205000
- メール：alvaro.garciagranero@ssib.es
研究連絡先のバックアップ
- 名前：Sebastian Jeri, MD, PhD
- 電話番号：+34871205000
- メール：sebastian.jeri@ssib.es
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete or Incomplete D3L
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Number of Lymph Nodes Retrieved
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment to 5 years
|
To assess overall survival at 5 years following right hemicolectomy with D3 lymphadenectomy. |
From enrollment to 5 years
|
協力者と研究者
協力者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Multicenter_D3L
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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