Powered Echelon Device in VATS Surgery

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808430
• Other study ID #: CME-12-001
• Status: Completed
• Phase: N/A
• First received: March 6, 2013
• Last updated: February 11, 2015
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Ethicon Endo-Surgery (Europe) GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Procedure:
• VATS for confirmed non-small cell lung cancer (NSCLC)
Video-Assisted Thoracoscopic Surgery for NSCLC patients

Locations

Country	Name	City	State
Denmark	Professor Peter Licht	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery (Europe) GmbH

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence and duration of post-operative air leak	occurrence and duration of prolonged air leak defined as longer than 5 days	prolonged air leak defined as longer than 5 days post-op	No
Secondary	volume of estimated intra-operative blood loss	volume of estimated intra-operative blood loss	blood loss intra-op and up to 5 days post-op	No