Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer

Официальное название

Randomized Multicenter Study Protocol: Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer

Обзор

The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.

Вмешательства

• Диагностический тест 3D reconstruction
  3D mathematical reconstruction from the extension CT, which is performed on all patients with colon neoplasms, to assess the location of the primary colon tumor and possible infiltration of neighboring/retroperitoneal structures.

Первичные конечные точки

• R0 resection rate [Срок оценки: 8 weeks]

Вторичные конечные точки (6)

• Rate of perioperative complications (Clavien-Dindo classification) [Срок оценки: Within 30 days after surgery]
• Rate of minimally invasive surgical approach [Срок оценки: Within 8 Weeks]
• Conversion to open surgery [Срок оценки: 8 Weeks]
• Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity) [Срок оценки: Within 8 Weeks]
• Overall survival (OS) [Срок оценки: Up to 5 years]
• Rate of locoregional and distant recurrence [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Patients of both sexes, aged ≥18 years.
• Adenocarcinoma of the right, left, sigmoid and recto-sigmoid junction that have cT3 or cT4a/b according to the eighth TNM edition of the American Joint Committee on Cancer (AJCC). Pre-treatment diagnosis by imaging (CT) test.
• Lymph node extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pretreatment diagnosis by imaging (CT) test.
• Patients who access and sign informed consent for the surgical intervention.

Критерии исключения

• Suspected carcinomatosis on preoperative CT or intraoperative finding
• Suspected distant metastasis on preoperative CT or intraoperative finding
• Patients with tumors with infiltration considered to be unresectable (pre-surgical or intraoperatively), since the anatomical-pathological analysis will not be available.

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

Двойное слепое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Garcia-Granero A, Jeri Mc-Farlane S, Gamundi Cuesta M, Gonzalez-Argente FX. Application of 3D-reconstruction and artificial intelligence for complete mesocolic excision and D3 lymphadenectomy in colon cancer. Cir Esp (Engl Ed). 2023 May;101(5):359-368. doi: 10.1016/j.cireng.2023.01.006. Epub 2023 Jan 26. PMID 36709852
• Jeri-McFarlane S, Garcia-Granero A, Ochogavia-Segui A, Pellino G, Oseira-Reigosa A, Gil-Catalan A, Brogi L, Ginard-Vicens D, Gamundi-Cuesta M, Gonzalez-Argente FX. Three-dimensional modelling as a novel interactive tool for preoperative planning for complex perianal fistulas in Crohn's disease. Colorectal Dis. 2023 Jun;25(6):1279-1284. doi: 10.1111/codi.16539. Epub 2023 Mar 27. PMID 36974360
• Garcia-Granero A, Jeri-McFarlane S, Torres-Mari N, Brogi L, Ferra-Canet M, Navarro Zoroa MA, Gamundi-Cuesta M, Gonzalez-Argente FX. 3D-reconstruction printed models and virtual reality improve teaching in oncological colorectal surgery. Tech Coloproctol. 2024 Dec 19;29(1):24. doi: 10.1007/s10151-024-03074-3. PMID 39699719
• Garcia-Granero A, Jeri-McFarlane S, Ochogavia A, Gamundi-Cuesta M, Garcia-Granero E, Gonzalez-Argente FX. 3D reconstructions in rectal cancer. New tools for better diagnosis and surgical planning. Cir Esp (Engl Ed). 2025 Sep;103(9):800198. doi: 10.1016/j.cireng.2025.800198. Epub 2025 Aug 7. PMID 40783150
• Jeri-McFarlane S, Garcia-Granero A, Ochogavia-Segui A, Ginard-Vicens D, Brogi L, Ferra-Canet M, Gamundi-Cuesta M, Gonzalez-Argente FX. 3D-reconstruction printed models could enhance understanding of Crohn's disease complex perianal fistulas? ANZ J Surg. 2025 Nov;95(11):2359-2366. doi: 10.1111/ans.70140. Epub 2025 May 14. PMID 40365997
• Torres-Mari N, Garcia-Fuster AG, Jeri-McFarlane S, Ochogavia-Segui A, Diaz-Ferrando J, Gomez-Gomes G, Gamundi-Cuesta M, Gonzalez-Argente FX. Anatomy-guided computational framework for classifying vascular ligation and lymphadenectomy in oncologic sigmoidectomy: toward AI-supported surgical auditing. Int J Colorectal Dis. 2026 Jan 3;41(1):12. doi: 10.1007/s00384-025-05046-x. PMID 41483146
• Jeri-McFarlane S, Garcia-Granero A, Martinez-Ortega MA, Amengual-Antich I, Robayo AR, Gamundi-Cuesta M, Gonzalez-Argente FX. Tailored-surgery for locally advanced colon cancer based on 3D mathematical reconstruction surgical planner: Observational comparative non-randomized study. Eur J Surg Oncol. 2025 Feb;51(2):109584. doi: 10.1016/j.ejso.2025.109584. Epub 2025 Jan 6. PMID 39808969
• Jeri-McFarlane S, Garcia-Granero A, Pellino G, Torres-Mari N, Ochogavia-Segui A, Rodriguez-Velazquez M, Gamundi-Cuesta M, Gonzalez-Argente FX. Prospective observational non-randomized trial protocol for surgical planner 3D image processing & reconstruction for locally advanced colon cancer. BMC Surg. 2024 Oct 7;24(1):292. doi: 10.1186/s12893-024-02558-1. PMID 39375653

Идентификаторы

NCT: NCT07528937 · IB 5113/23 PI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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