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

N/ANot Yet RecruitingNCT07528937

Fundació d'investigació Sanitària de les Illes Balears168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

168

Conditions

Colon Neoplasms Locally Advanced Colon Cancer 3D Reconstruction

Interventions

3D reconstructionDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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.

Central Contacts

Sebastian Jeri-McFarlane, MD, PhD

CONTACT

+34871205000 sebastian.jeri@ssib.es

Data from ClinicalTrials.gov

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