Powered Echelon Device in VATS Surgery

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)

• Registration Number: NCT01808430
• Lead Sponsor: Ethicon Endo-Surgery (Europe) GmbH

Brief Summary

This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).

Detailed Description

The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
• Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
• Willing to give consent and comply with evaluation and treatment schedule
• At least 18 years of age

Exclusion Criteria

• Active bacterial infection or fungal infection
• Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
• Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
• Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
• Prior history of VATS or open lung surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VATS for NSCLC patients	VATS for confirmed non-small cell lung cancer (NSCLC)	VATS for confirmed non-small cell lung cancer (NSCLC)

Primary Outcome Measures

Name	Time	Method
occurrence and duration of post-operative air leak	prolonged air leak defined as longer than 5 days post-op	occurrence and duration of prolonged air leak defined as longer than 5 days

Secondary Outcome Measures

Name	Time	Method
volume of estimated intra-operative blood loss	blood loss intra-op and up to 5 days post-op	volume of estimated intra-operative blood loss

Trial Locations

Locations (1)

Professor Peter Licht; 🇩🇰 Odense, Denmark