NCT04663191

Brief Summary

Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades \[either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)\], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy. The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
843

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

December 4, 2020

Last Update Submit

December 11, 2020

Conditions

Keywords

video-assisted thoracoscopic surgerylung-cancer surgeryintraoperative conversion to open surgerylobectomysurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival during the follow-up period after surgery

    from day of surgery up to 7 years

Study Arms (3)

Full VATS

Procedure: anatomical resection

VATS with conversion

Procedure: anatomical resection

Thoracotomy upfront

Procedure: anatomical resection

Interventions

Anatomical resection with systematic lymph-node dissection

Full VATSThoracotomy upfrontVATS with conversion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.

You may qualify if:

  • All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.

You may not qualify if:

  • patients with non-anatomical pulmonary resection (wedge resection)
  • patients with a histology other than NSCLC (benign or metastatic from another primitive cancer), stage IV NSCLC disease,
  • patients with multiple primary NSCLC (synchronous or metachronous)
  • patients with incomplete resection (R+)
  • patient for whom a VATS approach was never considered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 10, 2020

Study Start

January 2, 2020

Primary Completion

December 2, 2020

Study Completion

December 3, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations