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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196675
• Other study ID #: ESC-13-003
• Status: Completed
• Phase: N/A
• First received: July 19, 2014
• Last updated: December 28, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korean University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Volume of Estimated Intra-operative Blood Loss		Blood loss intra-op and up to 5 days post-op	No
Secondary	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	No