NCT03056300

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

Completed NA Results posted Last updated 30 January 2019

What this trial tests

NA trial testing Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler in Non-Small Cell Lung Cancer in 50 participants. Completed in 26 May 2017.

Timeline

11 January 2017

Primary endpoint
26 May 2017

26 May 2017

Quick facts

Lead sponsor	Ethicon, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	50
Start date	11 January 2017
Primary completion	26 May 2017
Estimated completion	26 May 2017
Sites	1 location across China

Drugs / interventions tested

• Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

Ethicon, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Intra-Operative Hemostatic Interventions Primary · 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).

Group	Value	95% CI
Powered Vascular Stapler	1.8	0.4 – 5.2

Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding Primary · 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).

Group	Value	95% CI
Powered Vascular Stapler	0	0.0 – 7.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Powered Vascular Stapler

Serious: 5/50 (10%)

Deaths: 0/50

Serious adverse events (4 terms)

Reaction	System	Powered Vascular Stapler
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Acute myocardial infarction	Cardiac disorders	—
Chylothorax	Respiratory, thoracic and mediastinal disorders	—
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (11 terms — click to expand)

Reaction	System	Powered Vascular Stapler
Pyrexia	General disorders	—
Pulmonary air leakage	Respiratory, thoracic and mediastinal disorders	—
Atrial fibrillation	Cardiac disorders	—
Chest discomfort	General disorders	—
Wound complication	Injury, poisoning and procedural complications	—
Blood albumin decreased	Investigations	—
Hyperglycaemia	Metabolism and nutrition disorders	—
Anxiety	Psychiatric disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Pneumothorax, Acute myocardial infarction, Chylothorax, Pulmonary haemorrhage.

Data from ClinicalTrials.gov NCT03056300 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical outcomes following an initial experience with a novel powered vascular stapler in video-assisted thoracoscopic lobectomies: results of a Chinese multi-center study.
   Qiu B, Kang X, Chen KN, Hu J, et al · · 2019 · cited 3× · PMID 31285890 · DOI 10.21037/jtd.2019.04.89