Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer

Официальное название

Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial

Обзор

An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.

Подробное описание

This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.

Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.

The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.

All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.

Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.

The study expected to last six and a half years, of which one and a half years for recruiting 416 patients, 208 each arm, with five years of follow-up. Patients will be followed up at 1, 4, 12, 24, 36, and 60 months postoperatively.

Вмешательства

• Процедура Conventional Right hemicolectomy (Non-CME)
  Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted.
• Процедура Right hemicolectomy with CME+CVL
  Separation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly: * The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery * The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as

Первичные конечные точки

• Disease-free survival at 3 years [Срок оценки: 3 Years.]

Вторичные конечные точки (12)

• Safety-Operative time. [Срок оценки: Intraoperative]
• Safety-Intraoperative blood loss. [Срок оценки: Intraoperative]
• Safety-Intraoperative blood transfusion. [Срок оценки: Intraoperative]
• Safety- Intraoperative Complications. [Срок оценки: Intraoperative]
• Early postoperative complications. [Срок оценки: 30 postoperative days.]
• Late postoperative complications. [Срок оценки: From the 31st postoperative days to the end of the study.]
• Safety- Length of stay. [Срок оценки: 30 Days.]
• Safety- Postoperative mortality rate. [Срок оценки: 30 Days.]
• Overall Survival at 3 years [Срок оценки: 3 Years.]
• Overall Survival at 5 years. [Срок оценки: 5 Years.]
• Disease-free survival. [Срок оценки: 5 Years.]
• Other Oncologic outcomes. [Срок оценки: 30 Days.]

Критерии участия

Критерии включения

• American Society of Anesthesiologists(ASA) grade I-III.
• Right colon cancer (\*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
• Informed consent

Критерии исключения

• Age > 85 years old.
• T1, N0
• T4b, any N
• BMI > 30.
• Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
• American Society of Anesthesiologists(ASA) grade IV.
• History of cancer in recent 5 years.
• Need for Emergency surgery.
• Infectious disease requiring treatment.
• Pregnancy.
• Use of systemic steroids.
• No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 14 центров

• Ospedale della Misericordia — Grosseto
• Ospedale Città di Sesto San Giovanni — Sesto San Giovanni
• S. Andrea Hospital — La Spezia
• Candiolo Cancer Institute - IRCCS — Candiolo
• Ospedale E. Agnelli Pinerolo — Pinerolo
• Maggiore Bellaria Hospital, Bologna — Bologna
• Università degli Studi di Ferrara — Ferrara
• Ospedale Policlinico San Martino — Genova
• … и ещё 6 центров

Публикации

• Bertelsen CA. Complete mesocolic excision an assessment of feasibility and outcome. Dan Med J. 2017 Feb;64(2):B5334. PMID 28157065
• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
• Benz S, Tannapfel A, Tam Y, Grunenwald A, Vollmer S, Stricker I. Proposal of a new classification system for complete mesocolic excison in right-sided colon cancer. Tech Coloproctol. 2019 Mar;23(3):251-257. doi: 10.1007/s10151-019-01949-4. Epub 2019 Mar 5. PMID 30838463
• Johnson PM, Porter GA, Ricciardi R, Baxter NN. Increasing negative lymph node count is independently associated with improved long-term survival in stage IIIB and IIIC colon cancer. J Clin Oncol. 2006 Aug 1;24(22):3570-5. doi: 10.1200/JCO.2006.06.8866. PMID 16877723
• Galizia G, Lieto E, De Vita F, Ferraraccio F, Zamboli A, Mabilia A, Auricchio A, Castellano P, Napolitano V, Orditura M. Is complete mesocolic excision with central vascular ligation safe and effective in the surgical treatment of right-sided colon cancers? A prospective study. Int J Colorectal Dis. 2014 Jan;29(1):89-97. doi: 10.1007/s00384-013-1766-x. Epub 2013 Aug 28. PMID 23982425
• West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2. PMID 22473170
• Bertelsen CA, Bols B, Ingeholm P, Jansen JE, Neuenschwander AU, Vilandt J. Can the quality of colonic surgery be improved by standardization of surgical technique with complete mesocolic excision? Colorectal Dis. 2011 Oct;13(10):1123-9. doi: 10.1111/j.1463-1318.2010.02474.x. PMID 20969719
• Kim NK, Kim YW, Han YD, Cho MS, Hur H, Min BS, Lee KY. Complete mesocolic excision and central vascular ligation for colon cancer: Principle, anatomy, surgical technique, and outcomes. Surg Oncol. 2016 Sep;25(3):252-62. doi: 10.1016/j.suronc.2016.05.009. Epub 2016 May 20. PMID 27566031

Идентификаторы

NCT: NCT04871399 · N.110/2019/U

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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