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

Lung Cancer Clinical Trial

— ICVATR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663191
• Other study ID #: T38
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: December 3, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: December 3, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lobectomy
• Lung Cancer
• Lung Neoplasms
• Surgery
• Survival
• Video-assisted Thoracoscopic Surgery

Intervention

Procedure:
• anatomical resection
Anatomical resection with systematic lymph-node dissection

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival during the follow-up period after surgery		from day of surgery up to 7 years