Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC

Lung Cancer Clinical Trial

Official title:

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348030
• Other study ID #: 17401
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: St. Joseph's Healthcare Hamilton
• Contact: Yogita S Patel, BSc
• Phone: 905-522-1155
• Email: patelys[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels <7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 120 years at time of consent
• Ability to speak and understand English
• Clinical stage I, II or IIIa NSCLC
• Candidate for RTS, as determined by the operating surgeon

Exclusion Criteria:

• Anticoagulation with inability to cease anticoagulant therapy prior to surgery
• Incurable coagulopathy
• Systemic vascular disease or vasculitis
• Not a candidate for RTS

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Medtronic Signia Stapler
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
• Vessel Sealer Extend Energy Device and SureForm Stapler
The Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection	Surgical device (stapler or energy) costs per surgery, along with inpatient hospitalization costs per day following surgery will be collected and evaluated in Canadian dollars.	Up to 3 weeks following hospital discharge
Secondary	Operating Room Time	Entry into Operating Room to Exit, in minutes	3 weeks post-surgery
Secondary	Length of Stay in Hospital	Admission Date to Discharge Date, in days	3 weeks post-surgery
Secondary	Duration of Chest Tube	Insertion Date to Discharge Date, in days	3 weeks post-surgery
Secondary	Intraoperative Complications and Adverse events (AEs)	Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.	3 weeks post-surgery