Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea

NCT ID: NCT02196675

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-01-31

Brief Summary

Collection of 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) in a Korean population.

Detailed Description

This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

VATS wedge resection or lobectomy

Single arm study Intervention: Device: Endocutter

Endocutter

Intervention Type: DEVICE

The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).

Interventions

Endocutter

The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
• Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
• Performance status 0-1 (Eastern Cooperative Oncology Group classification);
• ASA score ≤ 3;
• No prior history of VATS or open lung surgery;
• Willing to give consent and comply with study-related evaluation and treatment schedule; and
• At least 19 years of age.

Exclusion Criteria

• Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
• Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain 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);
• Pregnancy;
• Physical or psychological condition which would impair study participation;
• The patient is judged unsuitable for study participation by the Investigator for any other reason; or
• Unable or unwilling to attend follow-up visits and examinations.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elliott Fegelman, MD

Role: STUDY_DIRECTOR

Johnson & Johson

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Korean University Guro Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

ESC-13-003

Identifier Type: -

Identifier Source: org_study_id