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

• ClinicalTrials.gov Identifier: NCT03056300
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Results First Posted: December 17, 2018
• Last Update Posted: January 30, 2019
• Sponsor: Ethicon, Inc.
• Information provided by (Responsible Party): Ethicon, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: January 11, 2017
• Actual Primary Completion Date: May 26, 2017
• Actual Study Completion Date: May 26, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of Intra-Operative Hemostatic Interventions [ Time Frame: Intra-Operative ]
   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).
2. Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding [ Time Frame: Post-op through 4 week follow-up ]

   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).

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

China

Beijing Cancer Hospital

Beijing City, China

Sponsors and Collaborators

Ethicon, Inc.

Investigators

• Principal Investigator: Keneng Chen; Beijing Cancer Hospital
• 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 Documents (Full-Text)

Documents provided by Ethicon, Inc.:

Study Protocol  [PDF] February 11, 2016

Statistical Analysis Plan  [PDF] July 6, 2017

More Information

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT03056300
• Other Study ID Numbers: ESC-14-006
• First Posted: February 17, 2017
• Results First Posted: December 17, 2018
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases