Clinical trial · Interventional
Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer
Randomized Multicenter Study Protocol: Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer
NCT07528937CI-TRIAL-00108966not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 3D Reconstruction | — | UNRESOLVED | — |
| Colon Neoplasms | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D reconstruction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No 3D reconstruction group (Group A)
- description
- Group of patients in which 3D reconstruction is not going to be performed before surgery
- type
- EXPERIMENTAL
- label
- 3D Reconstruction Group (Group B)
- description
- Group of patients in which 3D reconstruction is going to be done before surgery
- interventionNames
- Diagnostic Test: 3D reconstruction
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- 8 weeks
- description
- Proportion of patients achieving R0 resection (defined as microscopically margin-negative resection) following surgical planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with threatened surgical margins (TSM) in locally advanced colon cancer (LACC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients of both sexes, aged ≥18 years. 2. 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. 3. 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. 4. Patients who access and sign informed consent for the surgical intervention. Exclusion Criteria: 1. Suspected carcinomatosis on preoperative CT or intraoperative finding 2. Suspected distant metastasis on preoperative CT or intraoperative finding 3. Patients with tumors with infiltration considered to be unresectable (pre-surgical or intraoperatively), since the anatomical-pathological analysis will not be available.
References
Publications (8)
- BACKGROUNDGarcia-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
- BACKGROUNDJeri-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
- BACKGROUNDGarcia-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
- BACKGROUNDGarcia-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
- BACKGROUNDJeri-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
- BACKGROUNDTorres-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.