Powered Echelon Device in VATS Surgery

NCT01808430 — Completed, 158 participants, Ethicon Endo-Surgery (Europe) GmbH

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

RegistryNCT01808430
StatusCompleted
Study typeObservational
Enrollment158 (Actual)
SponsorEthicon Endo-Surgery (Europe) GmbH (Industry)
ConditionsNon-small Cell Lung Cancer (NSCLC)
InterventionsVATS for confirmed non-small cell lung cancer (NSCLC) (Procedure)
Datesstart 2013-03-01, primary completion 2014-05-01, completion 2014-05-01, first posted 2013-03-11, last updated 2015-02-12
Locations1 site in Denmark

Related Papers Related Patents Related Grants Related Experts
All trials for Non-small Cell Lung Cancer (NSCLC) All trials of VATS for confirmed non-small cell lung cancer (NSCLC)

-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).

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
VATS for NSCLC patientsProcedure: VATS for confirmed non-small cell lung cancer (NSCLC)VATS for confirmed non-small cell lung cancer (NSCLC)
  • VATS for confirmed non-small cell lung cancer (NSCLC) (Procedure), also known as Video-Assisted Thoracoscopic Surgery: Video-Assisted Thoracoscopic Surgery for NSCLC patients

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Professor Peter LichtOdenseDenmark

+Investigators