Patients with locally advanced colon cancer and suspected infiltration in computed tomography scans Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with primary colon cancer located in the right, transverse and/or left colon by colonoscopy. Locally advanced tumors with suspected infiltration of neighboring structures and/or retroperitoneal margin or those considered as T3 or T4 (TNM staging classification) according to the radiologist's report from the extension CT. 2. Over 18 years of age 3. Patients who agree and sign informed consent for surgical intervention
Exclusion criteria
Exclusion criteria: 1. Preoperative chemotherapy or radiotherapy (neoadjuvant treatment) 2. Suspicion of carcinomatosis in preoperative CT scan 3. Suspected distant metastasis on preoperative CT scan 4. Patients with infiltrating tumors considered unresectable (preoperatively or intraoperatively), since anatomo-pathological analysis will not be available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The usefulness of 3D-IPR to obtain surgeries with R0 resection in patients with Threatened Surgical Margin (TSM); either by threatened retroperitoneal margin or suspected infiltration of neighboring structures in cancer of the right, transverse, and left colon. Qualitative variables will be expressed by sample size and percentage. Quantitative variables will be expressed by median and range. In non-parametric univariate analysis, continuous variables will be compared by the Kruskal-Wallis test, while categorical variables will be compared by the Fisher's Exact test. A p-value <0.05 will be considered statistically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The usefulness of 3D-IPR as a preoperative surgical strategy tool, comparing the diagnostic accuracy of 3D-IPR with the radiological CT report regarding the infiltration of neighboring structures and retroperitoneal margin in colon tumors with TSM: Mathematical 3D reconstruction is extracted from the pre-operative CT, which is performed in all patients with colon neoplasms, to assess the location of the primary colon tumor and possible infiltration of neighboring/retroperitoneal structures. 3D-IPR will be based on two concepts: 1.1. Preprocessing of the CT of extension using "Bias Field Correction" algorithms and anisotropic diffusion filters of the image. 1.2. Medical image segmentation in the different sequences provided using a sequence of algorithms based on active contour methods, modified dynamic search and based on atlases. Finally, the 3D surface will be reconstructed using modified "marching cubes" algorithms. After CT segmentation, 3D-IPR detects possible infiltration areas and marks them with red colouring. 3D-IPR will be compared to the anatomopathology report to confirm a complete or incomplete coincidence. Timepoints: 2.5 years 2. The usefulness of 3D-IPR to detect pathological or suspicious adenopathy: 3D-IPR uses segmentation to detect possible lymph nodes in the mesocolon. Suspicious adenopathies located in 3D-IPR will be confirmed in the anatomopathology report to confirm a complete or incomplete coincidence. Timepoints: 2.5 years 3. The use of 3D-IPR to point out the main vascularization, as well as the possible anatomical variants of the right and left colon: 3D-IPR uses segmentation from CT and creates a 3D render of all anatomical structures. This creates a more visual representation of the abdominal vascularization and may detect possible variants. Timepoints: 2.5 years 4. Oncological variables analysis at 3 and 5 years such as: 4.1. Loco-regional recurrence: intraluminal tumor growth near the suture or within the cavity near the previous | — |
Countries
Spain