Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07528937

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Colon Neoplasms 3D Reconstruction Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Locally Advanced Colon Cancer Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

3D reconstruction

Diagnostic Test

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.

Other names: Cella Medical Solutions

Primary outcomes

  1. R0 resection rate

    Time frame: 8 weeks

    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)

Secondary outcomes

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

    Time frame: Within 30 days after surgery

    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.

  2. Rate of minimally invasive surgical approach

    Time frame: Within 8 Weeks

    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).

  3. Conversion to open surgery

    Time frame: 8 Weeks

    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).

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

    Time frame: Within 8 Weeks

    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.

  5. Overall survival (OS)

    Time frame: Up to 5 years

    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).

  6. Rate of locoregional and distant recurrence

    Time frame: Up to 5 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Jeri-McFarlane, MD, PhD

CONTACT

[email protected]

+34871205000

Sponsors and collaborators

Lead sponsor

Fundació d'investigació Sanitària de les Illes Balears

Other Gov

Collaborators

  • Asociacion Española de Coloproctologia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Apr 14, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.