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Completed

NCT Number: NCT01808430

Powered Echelon Device in VATS Surgery

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).

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Professor Peter Licht

Odense, 5000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VATS for confirmed non-small cell lung cancer (NSCLC)

Procedure

Video-Assisted Thoracoscopic Surgery for NSCLC patients

Other names: Video-Assisted Thoracoscopic Surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery (Europe) GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2013
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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