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Not yet recruitingNCT07528937Updated Apr 21, 2026

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

An interventional study of 3D reconstruction in Colon Neoplasms, Locally Advanced Colon Cancer and 3D Reconstruction, sponsored by Fundació d'investigació Sanitària de les Illes Balears. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Fundació d'investigació Sanitària de les Illes Balears · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Colon Neoplasms
  • Locally Advanced Colon Cancer
  • 3D Reconstruction

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Keywords

  • Locally advanced colon cancer
  • Colon neoplasm
  • 3D Reconstruction
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
168 participants (estimated)

Study arms

  • No intervention
    No 3D reconstruction group (Group A)

    Group of patients in which 3D reconstruction is not going to be performed before surgery

  • Experimental
    3D Reconstruction Group (Group B)

    Group of patients in which 3D reconstruction is going to be done before surgery

    Diagnostic Test: 3D reconstruction

Interventions

  • Diagnostic test3D 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.

    Also known as: Cella Medical Solutions

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What researchers measure

Primary outcomes

  1. R0 resection rate

    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)

    Time frame: 8 weeks

Secondary outcomes

  1. Rate of perioperative complications (Clavien-Dindo classification)

    Proportion of patients experiencing perioperative complications within 30 days after surgery, classified according to the Clavien-Dindo grading system, following surgical planning with three-dimensional image post-processing reconstruction in patients with locally advanced colon cancer.

    Time frame: Within 30 days after surgery

  2. Rate of minimally invasive surgical approach

    Proportion of patients undergoing a minimally invasive surgical approach (laparoscopic or robotic) following preoperative planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with locally advanced colon cancer (LACC).

    Time frame: Within 8 Weeks

  3. Conversion to open surgery

    Proportion of patients requiring conversion from minimally invasive to open surgery during procedures planned with three-dimensional image post-processing reconstruction (3D-IPR) in patients with locally advanced colon cancer (LACC).

    Time frame: 8 Weeks

  4. Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity)

    Sensitivity and specificity of three-dimensional image post-processing reconstruction (3D-IPR) compared with conventional CT radiological reports for the detection of adjacent organ infiltration in patients with locally advanced colon cancer (LACC), using intraoperative findings and/or histopathological assessment as the reference standard.

    Time frame: Within 8 Weeks

  5. Overall survival (OS)

    Overall survival, defined as the time from surgery to death from any cause, in patients with locally advanced colon cancer (LACC) undergoing surgical planning with three-dimensional image post-processing reconstruction (3D-IPR).

    Time frame: Up to 5 years

  6. Rate of locoregional and distant recurrence

    Proportion of patients experiencing locoregional or distant recurrence within 5 years after surgery, confirmed by imaging studies (CT, MRI, or PET-CT) or histopathology, in patients with locally advanced colon cancer (LACC) undergoing surgical planning with three-dimensional image post-processing reconstruction (3D-IPR).

    Time frame: Up to 5 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 39375653 ↗

Study documents

  • Study protocol · Mar 29, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) from this study, including clinical variables and imaging-derived measurements, will be made available to qualified researchers. IPD will not be directly posted on ClinicalTrials.gov, but may be requested from the corresponding author. A methodologically sound research proposal must be submitted and approved by the study steering committee. Data sharing will comply with all applicable data protection regulations. Once data are available, a link to the repository will be provided in the Available IPD/Information field of the record. Researchers with a methodologically sound proposal can request access by contacting the corresponding author. Requests will be reviewed and approved by the study steering committee. Access will be granted after agreement to terms regarding confidentiality, ethical use, and compliance with data protection regulations.

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Registry details

Key details

Study ID
NCT07528937
Lead sponsor
Fundació d'investigació Sanitària de les Illes Balears
Collaborators
Asociacion Española de Coloproctologia
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
May 1, 2026 (estimated)
Primary completion
May 1, 2028 (estimated)
Completion
May 1, 2031 (estimated)
Last update
Apr 21, 2026

Study contacts

Sebastian Jeri-McFarlane, MD, PhD
Contact
sebastian.jeri@ssib.es
+34871205000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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