NCT05832112

Brief Summary

This study consists in a prospective pilot study evaluating the feasibility and safety of OTC RATS lobectomies in patients treated for lung cancer. All patients with clinical stage I tumors (≤cT2N0M0) planned to undergo a VATS or RATS lobectomy at the CHUM will be approached. At our institution, lobectomies are either performed open by thoracotomy or by MIS, including VATS and RATS. The technique is selected based on tumor size, tumor location and patient characteristics. Only patients already planned for a VATS or RATS lobectomy will be approached. They will be identified through the operation request forms and will be approached either in the preoperative clinic or the day before surgery, when admitted. The investigators aim to recruit 20 patients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Feb 2023Dec 2028

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

February 13, 2023

Last Update Submit

March 17, 2026

Conditions

Lung Cancer Stage I

Keywords

Out of the CageLobectomyRobotic

Outcome Measures

Primary Outcomes (2)

  • Conversion rate

    Feasibility will be evaluated by completion of the procedure without conversion of the approach or technique. Any change in the treatment plan requiring the use of intercostal ports, conversion to conventional minimally invasive thoracic surgery through intercostal incisions, or conversion to open surgery

    Through study completion, an average of 1 year

  • 30-day mortality

    Safety will be evaluated by 30-day mortality. Any dead occurring during the hospital stay or within 30 days after discharge will be registered.

    30 days after discharge

Secondary Outcomes (9)

  • Length of stay

    Through study completion, an average of 1 year

  • Operative time

    Intraoperative

  • Estimated blood loss

    Intraoperative

  • Postoperative pain

    Through study completion, an average of 1 year

  • Quality of recovery

    Through study completion, an average of 1 year

  • +4 more secondary outcomes

Study Arms (1)

Out of the Cage Robotic Lobectomy

EXPERIMENTAL

Consented patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, except for the incisions, that will consist in 1 to 4 subcostal ports, based on the patient and case characteristics.

Procedure: VATS/RATS lobectomy

Interventions

VATS/RATS lobectomyPROCEDURE

Consenting patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, aside from the ports that will be placed in the subcostal plane. The characteristics of both the patient and the case, will determine the number of incisions from 1-4. The Davinci Xi® surgical system will be used to perform the lobectomy through the ports using the standard technique with an anterior approach. Once the procedure is completed, the robotic arms and ports will be removed from the chest and figure-of-8 stitches with non absorbable sutures will be placed to close the diaphragm at the site of insertion. A 24 Fr soft chest tube will be left in place, as in the standard VATS/RATS lobectomy procedure. The incision closure will be done in a standard manner.

Out of the Cage Robotic Lobectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with clinical stage I tumors (≤cT2N0M0) planned to undergo a lobectomy by VATS/RATS at the CHUM

You may not qualify if:

  • Age \< 18 years old
  • Inability to consent to the study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Moishe Liberman, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

April 27, 2023

Study Start

February 22, 2023

Primary Completion (Estimated)

December 9, 2027

Study Completion (Estimated)

December 9, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)