A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies

The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing City, China
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
2. Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
3. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
4. ASA score < 3;
5. No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed);
6. Willing to give consent and comply with study-related evaluation and treatment schedule; and
7. 18-75 years of age (inclusive).

Exclusion Criteria:

1. Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
2. Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
3. Uncontrolled diabetes mellitus;
4. End stage renal or liver disease;
5. History of severe cardiovascular disease;
6. FEV1% <50% or severe COPD;
7. Prior chemotherapy or radiation for lung cancer;
8. Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
9. Robotic-assisted procedure;
10. Women who are pregnant or lactating at the time of screening;
11. Physical or psychological condition which would impair study participation;
12. The subject is judged unsuitable for study participation by the Investigator for any other reason;
13. Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
14. Unable or unwilling to attend follow-up visits and examinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Powered vascular stapler; Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler	Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler; Powered Vascular Stapler used on vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Intra-Operative Hemostatic Interventions	Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).	Intra-Operative
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding	Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS: Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).	Post-op through 4 week follow-up

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Principal Investigator: Keneng Chen, Peking University Cancer Hospital & Institute; Principal Investigator: Shugeng Gao, Cancer Institute and Hospital, Chinese Academy of Medical Services; Principal Investigator: Hu Jian, The first affiliated hospital Zhejiang University/Hangzhou; Principal Investigator: Li Jian, Beijing Friendship hospital/Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Actual): May 26, 2017
• Study Completion (Actual): May 26, 2017

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

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-14-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No