Clinical trial NCT02338583: Powered Surgical Stapler in VATS Lung Resection Procedures in China
Official title: A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals scheduled for VATS lobectomy or diagnostic VATS wedge resection in accordance with their institution's SOC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of prolonged air leaks
timeFrame: 30 days
Secondary outcomes:
measure: 2.Occurrence of postoperative air leaks
timeFrame: 30 days
measure: Length of stay (LOS)
timeFrame: 30 days
measure: Volume of estimated intra-operative blood loss
timeFrame: Intra-operative
measure: 5.Time to chest tube removal
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Wuhan Tongji Hospital
Study officials:
References: