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

Ethicon

Status: Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Device: Endocutter

Study type: Observational

Funder types: Industry

Identifiers

NCT02196675

ESC-13-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

105 participants in 1 patient group

VATS wedge resection or lobectomy

Description:

Single arm study Intervention: Device: Endocutter

Treatment:

Device: Endocutter