Powered Echelon Device in VATS Surgery

February 11, 2015 updated by: Ethicon Endo-Surgery (Europe) GmbH

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Professor Peter Licht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VATS for NSCLC patients
VATS for confirmed non-small cell lung cancer (NSCLC)
Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)
Video-Assisted Thoracoscopic Surgery for NSCLC patients
Other Names:
  • Video-Assisted Thoracoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence and duration of post-operative air leak
Time Frame: prolonged air leak defined as longer than 5 days post-op
occurrence and duration of prolonged air leak defined as longer than 5 days
prolonged air leak defined as longer than 5 days post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of estimated intra-operative blood loss
Time Frame: blood loss intra-op and up to 5 days post-op
volume of estimated intra-operative blood loss
blood loss intra-op and up to 5 days post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery (Europe) GmbH

Investigators

  • Study Chair: Goran Ribaric, MD, MSc, PhD, Ethicon Endo-Surgery (Europe) GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 8, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CME-12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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