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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT04663191

Collaborator

(none)

843

Enrollment

Location

Actual Duration (Months)

76.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Video-assisted Thoracoscopic Surgery Lung Cancer Lobectomy Survival Surgery	Procedure: anatomical resection

Study Design

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 :

Jan 2, 2020

Actual Primary Completion Date :

Dec 2, 2020

Actual Study Completion Date :

Dec 3, 2020

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Overall survival during the follow-up period after surgery [from day of surgery up to 7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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