3D reconstruction for the assessment of tumor infiltration in colon cancer
| ISRCTN | ISRCTN81005215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81005215 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IB 5113/23 PI |
| Sponsor | Health Research Institute of the Balearic Islands |
| Funders | Asociación Española de Coloproctología, Hospital Universitario Son Espases |
- Submission date
- 26/01/2024
- Registration date
- 28/02/2024
- Last edited
- 07/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Surgical treatment of locally advanced colon cancer (suspected infiltration of neighboring structures) requires interventions with a high rate of complications and risk of death. The most important prognostic factor for survival is to achieve surgery with infiltration-free margins, known as surgery with R0 resection. Despite imaging and technological advances, infiltrated surgical margin rates remain high for this type of tumor due to the complexity of the procedures. The preoperative surgical strategy is important in deciding how the tumor will be approached surgically and a change in surgical strategy must be made to obtain an optimal resection. If the operating surgeons could have a preoperative 3D reconstruction of the case, this would help them to have a better idea of the lesion. In this way, it could allow surgeons to prepare the surgical intervention beforehand and try to find the best surgical route for each given case. In addition, the surgeon can practice the upcoming surgery on the 3D print or visualize it on the computer to virtually walk through and experiment with the anatomical part that he or she will be facing on the operating table days later. As these are surgeries that sometimes require resection of multiple structures or extended resections, the preoperative strategy is essential to decide which organs should be removed together with the colon cancer. Preoperative simulation using 3D printing could help to get a more accurate idea of the structures involved and whether a more extensive resection is necessary. This study aims to assess whether 3D models in locally advanced colon cancer (right, transverse or left) are useful to improve the care provided to patients, improve surgical indications, and assess the anatomical variants of the blood vessels that irrigate the colon and thus try to reduce the rate of complications in this type of surgery.
Who can participate?
Patients over 18 years of age 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.
What does the study involve?
A computed tomography (CT) scan will be performed to define the colon tumor (staging) before surgery. With this CT scan, the 3D model reconstruction is performed.
In a multidisciplinary committee the CT result is used to decide which type of surgical intervention is best. The tumor is analyzed with the anatomic pathology team and compared with the 3D and CT models performed. Information will be collected for 1 year and a half.
What are the possible benefits and risks of participating?
If the operating surgeons could have a preoperative 3D reconstruction of the case, this would help them to have a better idea of the lesion. It could allow surgeons to prepare the surgical intervention beforehand and try to find the best surgical route for each given case. In addition, the surgeon can practice the upcoming surgery on the 3D print or visualize it on the computer to virtually walk through and experiment with the anatomical part that he or she will be facing on the operating table days later. As these are surgeries that sometimes require resection of multiple structures or extended resections, the preoperative strategy is essential to decide which organs should be removed together with the colon cancer. Preoperative simulation using 3D printing could help to get a more accurate idea of the structures involved and whether a more extensive resection is necessary.
The risks of this study are the same as the risks derived from the surgery itself, which the researchers want to find out whether it is possible to reduce the risks with the use of reconstruction with 3D models. There are no risks associated with CT scanning since this is a mandatory step in the staging of colon tumors and should be performed in all patients who wish to treat their disease.
Where is the study run from?
Hospital Universitario Son Espases (Spain)
When is the study starting and how long is it expected to run for?
February 2023 to June 2025
Who is funding the study?
1. Asociación Española de Coloproctología (Spain)
2. Hospital Universitario Son Espases (Spain)
Who is the main contact?
Dr Sebastián Jerí Mc Farlane, Sebastian.jeri@ssib.es
Contact information
Scientific, Principal investigator
Carretera de Valldemosa 79
Palma
07120
Spain
 ORCID ID |
0000-0003-1644-1241 |
|---|---|
| Phone | +34 (0)678411230 |
| alvarogggf@hotmail.com |
Public, Scientific
Carretera de Valldemosa 79
Palma
07120
Spain
| ORCID ID |
0000-0003-0319-2872 |
|---|---|
| Phone | +34 (0)691860296 |
| Sebastian.jeri@ssib.es |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational non-randomized trial |
| Secondary study design | Cross sectional study |
| Participant information sheet | 44952_PIS_V2.0_31Oct22.pdf |
| Scientific title | 3D image processing and reconstruction for the assessment of tumor infiltration in colon cancer: prospective observational non-randomized trial |
| Study acronym | 3D-IPR, TUMOR INFILTRATION |
| Study objectives | A 3D image processing and reconstruction (IPR) model based on mathematical algorithms from CT could improve the diagnostic accuracy of suspected tumor infiltration of the retroperitoneal margin and neighboring structures in advanced tumors of the right, transverse, and left colon. This is a novel tool to establish a correct surgical strategy with the aim of increasing the percentage of R0-type resection in this type of tumors. |
| Ethics approval(s) |
Approved 29/06/2023, Comité De Ética De La Investigación De Las Islas Baleares (C. del calçat, 2 A, 2n, Palma, 07011, Spain; +34 (0)971177378; ceic_ib@caib.es), ref: IB 5113/23 PI |
| Health condition(s) or problem(s) studied | Patients with locally advanced colon cancer and suspected infiltration in computed tomography scans |
| Intervention | For 2 years, the colorectal unit will carry out the study: 1. Identification of patients who are candidates for the study according to material and methods in the protocol 2. Referral of the pre-operative CT scan to CELLA Medical Innovation and Technology (software owner) for the elaboration of the 3D reconstruction and assessment of tumor infiltration 3. Surgical intervention 4. Detailed microscopic study of the surgical specimen and definitive anatomopathological report 5. Incorporation of data into the prospective database During the following 6 months, the analysis of results will be carried out, and assessment of strategies and communication of the results. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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: |
| Completion date | 01/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 21 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/06/2023 |
| Date of final enrolment | 01/02/2025 |
Locations
Countries of recruitment
- Spain
Study participating centre
Palma
07120
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The name of the repository: Cloud servers owned by Oracle (https://apex.oracle.com/pls/apex/r/estudio_colon_3d/estudiocolon3d/login_desktop) The type of data stored: The information is encrypted so any direct access to it is useless unless the private key is known. No data that could be used to locate the patient such as name, surname, ID number, etc, is requested. The only data that could be used is the Clinical history ID, which is trimmed so that the user who reports data can locate the correspondence in their hospital, i.e. they must have the real data written down in some place controlled only by them (such as the hospital management program itself) to be able to locate that patient. In the event of access to the application by someone unauthorized but who has obtained a username and password with access to read patients from their own and other hospitals, the information available does not serve to "de-anonymize" the data. The accesses to the application, writings, readings, etc, are registered by the application so that any access without express authorization can be located. The process for requesting access (if non-publicly available): The main researcher is the only one who can create a new user and password for access to the database. Users can only view records that they have uploaded, and records from other users cannot be seen or edited. Whether consent from participants was required and obtained: Participants must sign an informed consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/01/2025 | 07/02/2025 | Yes | No | |
| Protocol article | 07/10/2024 | 08/10/2024 | Yes | No | |
| Participant information sheet | version 2.0 | 31/10/2022 | 26/02/2024 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 26/02/2024 | No | No |
Additional files
- 44952_PIS_V2.0_31Oct22.pdf
- Participant information sheet
- 44952_PROTOCOL.pdf
- Protocol file
Editorial Notes
07/02/2025: Publication reference and total final enrolment added.
08/10/2024: Publication reference added.
26/01/2024: Study's existence confirmed by the Comité De Ética De La Investigación De Las Islas Baleares.
