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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació d'investigació Sanitària de les Illes Balears

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: No 3D reconstruction group (Group A)No intervention 0 interventions
Group B: 3D Reconstruction Group (Group B)Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundació d'investigació Sanitària de les Illes Balears

Lead sponsor

Asociacion Española de Coloproctologia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: