Powered Surgical Stapler in VATS Lung Resection Procedures in China

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT02338583
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled.

Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-14
• Primary Completion: 2015-04-01
• Study Completion: 2015-05-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. 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);
2. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
3. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
4. ASA score < 3;
5. No prior history of VATS or open lung surgery;
6. Willing to give consent and comply with study-related evaluation and treatment schedule; and
7. At least 18 years of age.

Exclusion Criteria

Subjects satisfying the following criteria will be eligible for participation in this study:

1. 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);
2. Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
3. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
4. ASA score < 3;
5. No prior history of VATS or open lung surgery;
6. Willing to give consent and comply with study-related evaluation and treatment schedule; and
7. At least 18 years of age.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of prolonged air leaks	30 days

Secondary Outcome Measures

Name	Time	Method
5.Time to chest tube removal	30 days
2.Occurrence of postoperative air leaks	30 days
Length of stay (LOS)	30 days
Volume of estimated intra-operative blood loss	Intra-operative

Trial Locations

Locations (3)

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Cancer Institute & Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Wuhan Tongji Hospital; 🇨🇳 Beijing, China