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

A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Device: Endocutter

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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 152-703
    • Korean University Guro Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals with 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);

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VATS wedge resection or lobectomy; Single arm study Intervention: Device: Endocutter	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Prolonged Air Leaks	Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).	Post-operative period through hospital discharge and follow-up at Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (LOS)	Determined as the length of time in days from hospital admission to initial hospital discharge	Post-operative period through hospital discharge and follow-up at Day 30
Volume of Estimated Intra-operative Blood Loss		Blood loss intra-op and up to 5 days post-op
Time to Chest Tube Removal	Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.	Post-operative period through hospital discharge and follow-up at Day 30
Occurrence of Postoperative Air Leaks	Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).	Post-operative period through hospital discharge and follow-up at Day 30

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Study Director: Elliott Fegelman, MD, Johnson & Johson

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 19, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ESC-13-003