3D Reconstruction, Colon Neoplasms, Locally Advanced Colon Cancer
Conditions
Keywords
Locally advanced colon cancer, Colon neoplasm, 3D Reconstruction
Brief 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.
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.
Sponsors
Fundació d'investigació Sanitària de les Illes Balears
Asociacion Española de Coloproctologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of perioperative complications (Clavien-Dindo classification) | 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. |
| Rate of minimally invasive surgical approach | 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). |
| Conversion to open surgery | 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). |
| Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity) | 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. |
| Overall survival (OS) | 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). |
| Rate of locoregional and distant recurrence | 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). |
Contacts
CONTACTSebastian Jeri-McFarlane, MD, PhD
Outcome results
None listed