Surgical Navigation System for Thoracic Wall Surgery

(INSPIRE Trial)

Overseen By Judy McConnell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Unresectable lesions, Metallic implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

While undergoing chest wall resection, a surgeon's major concern is obtaining an appropriate surgical margin. Difficulty or failure to do so can result in prolonged operative time, need for re-operation due to a positive resection margin, or need for complex chest wall reconstruction due to unnecessarily wide resection. Over the last decades, surgical navigation systems have been developed to improve operative precision in various surgical fields. This is achieved by integrating patient images with intraoperative findings.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Surgical Navigation System treatment for thoracic wall surgery?

Research on similar navigation systems in other types of surgeries, like maxillofacial and cardiac surgeries, shows that these systems help surgeons plan and monitor operations more effectively. Additionally, a study on a thoracoscopic navigation system for chest wall tumors demonstrated improved accuracy in locating tumors and resection margins, which suggests potential benefits for thoracic wall surgery. ^{1 2 3 4 5}

Is the Surgical Navigation System safe for use in surgeries?

Research shows that surgical navigation systems, used in various types of surgeries like spinal and endonasal (inside the nose) procedures, are generally safe and help improve surgical precision, which can reduce complications. ^{6 7 8 9 10}

How is the Surgical Navigation System treatment different from other treatments for thoracic wall surgery?

The Surgical Navigation System is unique because it uses computer graphics and image processing to create real-time 2D or 3D models, helping surgeons precisely locate surgical instruments in relation to the patient's anatomy during thoracic wall surgery. This real-time visualization and spatial localization make it different from traditional surgical methods that rely more on the surgeon's direct visual and tactile feedback. ^{3 4 11 12 13}

Eligibility Criteria

The INSPIRE trial is for adults who need surgery to remove a lesion from their chest wall. They must be able to understand and agree to the study by signing consent forms. Pregnant individuals, those with conditions making surgery unsafe, or those with metal implants that could interfere with the navigation system are not eligible.

Inclusion Criteria

Ability to provide informed consent

I am 18 years old or older.

Must sign and be given a copy of the written informed consent form

Exclusion Criteria

Pregnant, lactating, or planning to become pregnant during the period of the evaluation

My condition or tumor cannot be treated with surgery.

Participants with metallic implantation, such as ribs fixations, a pacemaker, or pedicle screws, which may affect the accuracy of CBCT

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo imaging and surgery using intraoperative navigation systems for precise chest wall resection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• Surgical Navigation System

Trial Overview Surgeons in this trial will use a surgical navigation system during chest wall resection procedures. The goal is to see if this technology helps them achieve more precise removal of lesions while avoiding unnecessary damage or additional surgeries.

Participant Groups

Group I: SNS Experimental Treatment 1 Intervention

Intraoperative imaging/surgical navigation system (SNS)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Intraoperative computer-assisted navigation, using a wireless passive marker system, enhances the precision of maxillofacial surgeries by allowing real-time tracking of instruments and displaying virtual anatomical structures during operations.

A case report of a T3N2bM0 carcinoma resection demonstrated that the Stryker Navigation Cart System effectively supported both preoperative planning and intraoperative monitoring, suggesting its potential to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral and maxillofacial surgery with computer-assisted navigation system. Kawachi, H., Kawachi, Y., Ikeda, C., et al.[2019]

The study successfully transferred navigation software to modern high-power notebook computers, demonstrating that intraoperative positional information can be effectively provided to surgeons during endoscopic endonasal surgery.

The ARTMA Virtual Patient System, when used with the Polhemus FASTRAK digitizer, achieved satisfactory navigation using various medical imaging modalities, indicating its potential for practical use in operating rooms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A full 3D-navigation system in a suitcase. Freysinger, W., Truppe, MJ., Gunkel, AR., et al.[2006]

Surgical navigation systems enhance surgical precision by using advanced computer graphics and image processing to create real-time 2D or 3D models of medical images, allowing surgeons to accurately track the position of surgical instruments during procedures.

Key techniques in these systems include spatial localization, image processing, and head location tracking, which collectively improve the effectiveness and safety of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted surgical navigation technique]. Hao, Y., Zhu, F.[2006]

A new computer-assisted system for minimally invasive cardiac surgery was developed, focusing on optimized port placement and real-time navigation using an optical tracker, which enhances surgical precision.

Clinical tests and experiments showed that the system achieved a fiducial registration error of just 1.08 mm, indicating high accuracy in tracking surgical instruments relative to the patient's anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of an integrated computer-assisted system for minimally invasive cardiac surgery. Cai, J., Luo, Z., Gu, L., et al.[2014]

The newly developed thoracoscopic surgical navigation system significantly improved the accuracy of tumor localization and resection margins, particularly for areas that are hard to see with traditional thoracoscopy, as evidenced by reduced localization errors for the medial and superior tumor margins.

Surgeons reported a substantial decrease in workload and frustration when using the navigation system, with over a 50% reduction in performance and frustration scores, indicating increased confidence during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Thoracoscopic Navigation System With Augmented Real-Time Image Guidance for Chest Wall Tumors. Lee, CY., Chan, H., Ujiie, H., et al.[2019]

In a study of 16 patients undergoing thoracoscopic discectomy, frameless stereotactic image guidance improved surgical accuracy, with registration and navigation errors measured at just 1.7 mm and 1.2 mm, respectively.

The use of image guidance did not significantly increase the overall procedure time and resulted in clinical outcomes and complication rates comparable to previous surgical experiences, suggesting enhanced safety and efficiency in complex spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided thoracoscopic spinal surgery: a merging of 2 technologies. Johnson, JP., Stokes, JK., Oskouian, RJ., et al.[2019]

In a study of 8,500 patients undergoing lumbar spine surgery, the use of computer-assisted navigation significantly reduced overall complications (24% vs. 27%) and minor complications (20% vs. 24%), as well as the need for blood transfusions (17% vs. 20%).

While navigation improved safety outcomes and shortened hospital stays, it also resulted in longer surgical times and a higher rate of wound dehiscences, indicating a trade-off between benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted Navigation in Lumbar Spine Instrumented Fusions: Comparison of In-hospital and 30-Day Postoperative Complications With Nonnavigated Fusions in a National Database. Sing, D., Cummins, DD., Burch, S., et al.[2023]

The study evaluated the precision of the SMN navigation system for drilling in the lower jaw, finding an average drilling depth of 6.23 mm with a mean distance of only 0.14 mm from the mandibular canal, indicating high accuracy in implant placement.

Out of 100 drillings, 89 were successful without perforating the canal, demonstrating the system's effectiveness, although there were 11 instances of minor perforation, highlighting the need for careful navigation during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigational precision of drilling tools preventing damage to the mandibular canal. Gaggl, A., Schultes, G., Kärcher, H.[2021]

In a multicenter study involving 311 patients and 36 surgeons, the use of the DigiPointeur® surgical navigation system (SNS) allowed for more extensive surgical procedures in 81% of cases, particularly by helping to identify and open additional anatomical structures.

Surgeons reported high satisfaction with the SNS, averaging 8.6 out of 10, and noted a significant reduction in surgical stress in 95% of cases, indicating that the SNS not only enhances surgical performance but also improves the overall experience for the surgeon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a navigation system in endonasal surgery: Impact on surgical strategy and surgeon satisfaction. A prospective multicenter study. Vicaut, E., Bertrand, B., Betton, JL., et al.[2020]

Navigation systems, particularly 3D navigation, enhance precision in surgeries like pelvic and spine operations, leading to increased patient safety and reduced radiation exposure.

While these systems offer significant benefits, such as less invasive procedures, they come with high initial costs and require surgeons to be well-trained in both navigated and non-navigated techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does navigation still have a value in trauma surgery?] Oberthür, S., Sehmisch, S., Weiser, L., et al.[2022]

The newly developed surgical navigation system achieved high accuracy, with a target registration error of only 0.20 mm in a technical phantom model and 0.28 mm in ex vivo assessments, indicating it can reliably assist in delicate ear and skull base surgeries.

The system successfully integrated with endoscopic workflows during 36 procedures, allowing for accurate identification of vital anatomical structures without interfering with the surgical instruments, showcasing its potential for enhancing surgical precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and feasibility of a dedicated image guidance solution for endoscopic lateral skull base surgery. Rathgeb, C., Anschuetz, L., Schneider, D., et al.[2018]

A new navigation system was developed to enhance minimally invasive esophagectomy by providing real-time visualization of surgical instruments in relation to tumors and anatomical structures, potentially improving surgical precision.

The system demonstrated high accuracy with a precision of 0.95 +/- 0.78 mm in a phantom study, suggesting it could help surgeons navigate effectively to tumors and lymph nodes during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a navigation system for minimally invasive esophagectomy. Kenngott, HG., Neuhaus, J., Müller-Stich, BP., et al.[2018]

In a study involving 10 pigs, researchers found that the esophagus experiences significant motion during respiration, particularly at the lower thoracic level and gastroesophageal junction, which can affect surgical navigation accuracy.

The creation of pneumoperitoneum caused notable displacement of the esophagus, highlighting the need for navigation systems to account for soft tissue deformation during thoracoabdominal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer tomographic analysis of organ motion caused by respiration and intraoperative pneumoperitoneum in a porcine model for navigated minimally invasive esophagectomy. Nickel, F., Kenngott, HG., Neuhaus, J., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Oral and maxillofacial surgery with computer-assisted navigation system. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A full 3D-navigation system in a suitcase. [2006]

3. China pubmed.ncbi.nlm.nih.gov

[Computer-assisted surgical navigation technique]. [2006]

4. England pubmed.ncbi.nlm.nih.gov

The implementation of an integrated computer-assisted system for minimally invasive cardiac surgery. [2014]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Novel Thoracoscopic Navigation System With Augmented Real-Time Image Guidance for Chest Wall Tumors. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Image-guided thoracoscopic spinal surgery: a merging of 2 technologies. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted Navigation in Lumbar Spine Instrumented Fusions: Comparison of In-hospital and 30-Day Postoperative Complications With Nonnavigated Fusions in a National Database. [2023]

8. Scotland pubmed.ncbi.nlm.nih.gov

Navigational precision of drilling tools preventing damage to the mandibular canal. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Use of a navigation system in endonasal surgery: Impact on surgical strategy and surgeon satisfaction. A prospective multicenter study. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

[Does navigation still have a value in trauma surgery?] [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Accuracy and feasibility of a dedicated image guidance solution for endoscopic lateral skull base surgery. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

Development of a navigation system for minimally invasive esophagectomy. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

Computer tomographic analysis of organ motion caused by respiration and intraoperative pneumoperitoneum in a porcine model for navigated minimally invasive esophagectomy. [2019]