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Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival (ICVATR)

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ClinicalTrials.gov Identifier: NCT04663191
Recruitment Status : Completed
First Posted : December 10, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.


Condition or disease Intervention/treatment
Video-assisted Thoracoscopic Surgery Lung Cancer Lobectomy Survival Surgery Procedure: anatomical resection

Study Design
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Study Type : Observational
Actual Enrollment : 843 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival
Actual Study Start Date : January 2, 2020
Actual Primary Completion Date : December 2, 2020
Actual Study Completion Date : December 3, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Full VATS Procedure: anatomical resection
Anatomical resection with systematic lymph-node dissection
VATS with conversion Procedure: anatomical resection
Anatomical resection with systematic lymph-node dissection
Thoracotomy upfront Procedure: anatomical resection
Anatomical resection with systematic lymph-node dissection


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival during the follow-up period after surgery [ Time Frame: from day of surgery up to 7 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663191


Locations
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France
CHU Amiens
Amiens, France, 80480
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04663191    
Other Study ID Numbers: T38
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
video-assisted thoracoscopic surgery
lung-cancer surgery
intraoperative conversion to open surgery
lobectomy
survival
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases