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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer (NSCLC)

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Trial Information

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


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

occurrence and duration of post-operative air leak

Outcome Description:

occurrence and duration of prolonged air leak defined as longer than 5 days

Outcome Time Frame:

prolonged air leak defined as longer than 5 days post-op

Safety Issue:

No

Principal Investigator

Goran Ribaric, MD, MSc, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ethicon Endo-Surgery (Europe) GmbH

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CME-12-001

NCT ID:

NCT01808430

Start Date:

March 2013

Completion Date:

October 2014

Related Keywords:

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

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