3D reconstruction for the assessment of tumor infiltration in colon cancer
| ISRCTN | ISRCTN81005215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81005215 |
| Secondary identifying numbers | IB 5113/23 PI |
- 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
| Study design | Prospective observational non-randomized trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Medical and other records |
| Study type | Diagnostic, Treatment |
| 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 | 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 outcome measures | 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 previously operated location. 4.2. Distant recurrence: distant metastasis outside the abdominal cavity. 4.3. Peritoneal carcinomatosis: It will be considered carcinomatosis when there are tumor implants in at least two different areas of the abdominal cavity with anatomopathological diagnosis of the presence of tumor cellularity. This makes it possible to differentiate it from loco-regional recurrence. 4.4. Disease-free survival: time from surgery to the date on which recurrence is documented 4.5. Overall survival: time from admission to death from any cause (includes 90-day post-operative mortality) 4.6. Mortality due to oncologic progression |
| Overall study start date | 01/02/2023 |
| Completion date | 01/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | As this is an innovative study in which a preoperative technique utility is going to be used and has not been analyzed yet, there is no previous bibliography. The study will be carried out in all cases that meet the inclusion and exclusion criteria established in a colorectal unit at the reference hospital. It is considered that the number of patients operated in a reference colorectal unit will be around 20 patients per year with the characteristics described in the methodology. |
| 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
Sponsor information
Research organisation
Edificio S, Hospital Universitario Son Espases, Carretera de Valldemossa, 79
Palma
07120
Spain
| Phone | +34 (0)871205234 |
|---|---|
| idisba.calidad@ssib.es | |
| Website | http://www.idisba.es |
"ROR" |
https://ror.org/037xbgq12 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Spanish Association of Coloproctology, The Spanish Association of Coloproctologyl, La Asociación Española de Coloproctología, AECP
- Location
- Spain
No information available
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The primary goal of the dissemination plan is to share the groundbreaking research findings from this project with the broader society, including medical professionals, researchers, cancer patients, and the public. By effectively communicating their achievements, the researchers aim to raise awareness, promote understanding, and contribute to advancements in colon cancer treatment. The dissemination plan will be implemented throughout the project timeline, with ongoing activities to ensure continuous engagement and impact assessment. Regular reviews and adjustments will be made based on feedback and changing circumstances. Active participation in national and international conferences, symposia, and workshops is planned for engaging with professionals in the field. This includes the National Congress of Surgery (Asociación Española de Cirujanos), National Congress of Coloproctology (Asociación Española de Coloproctología – AECP), International Congress of European and American Coloproctology and European Congress of Endoscopic Surgery. To enhance scientific visibility, research findings will be submitted to prestigious medical journals with a high impact factor (most likely a Q1 Journal Citation Reports - JCR), being previously translated by an English expert. Media outreach through press releases, interviews, and social media will ensure broader visibility. |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 31/10/2022 | 26/02/2024 | No | Yes |
| Protocol file | 26/02/2024 | No | No | ||
| Protocol article | 07/10/2024 | 08/10/2024 | Yes | No | |
| Results article | 06/01/2025 | 07/02/2025 | Yes | No |
Additional files
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.
