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

NCT06348030 | Not Yet Recruiting

• 1 other identifier: 17401
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operating Room Time

  3 weeks post-surgery

• Length of Stay in Hospital

  3 weeks post-surgery

• Duration of Chest Tube

  3 weeks post-surgery

• Intraoperative Complications and Adverse events (AEs)

  3 weeks post-surgery

Study Arms (2)

Surgeon-Assisted

ACTIVE COMPARATOR

Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.

Device: Medtronic Signia Stapler

Totally Robotic

EXPERIMENTAL

Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

Device: Vessel Sealer Extend Energy Device and SureForm Stapler

Interventions

Medtronic Signia Stapler DEVICE

The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.

Surgeon-Assisted

Vessel Sealer Extend Energy Device and SureForm Stapler DEVICE

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.

Totally Robotic

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Waël C Hanna, MDCM, MBA, FRCSC

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yogita S Patel, BSc

CONTACT

905-522-1155; patelys@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head & Associate Professor, Division of Thoracic Surgery, McMaster University

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)