Feasibility study of Powered ECHELON FLEX 7 for segmental bronchus

JRCT ID: jRCTs062180039

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: lung cancer
• Date of first enrollment: 18/10/2017
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Stapling of bronchus by Powered ECHELON FLEX@ 7

Outcome(s)

• Primary Outcome: bronchopleural fistula rate 1 month after surgery
• Secondary Outcome: Number and rate of device malfunctions and adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients likely to undergo segmental resection (less than 2 segments) using Powered ECHELON FLEX@ 7
2) Age 20 years or older
3) Performance status 0 or 1 (ECOG classification)
4) Sufficient function of major organs
5) Written informed consent for participation in the study

Exclude criteria

1) Patients likely to undergo 3 segmental resections all together, such as basal or left upper division segmentectomy. Patients likely to undergo 3 segmental resections whose bronchus would be resected separately are not excluded.
2) Active bacterial and/or fungal infection
3) Continuous use of systemic steroids
4) Uncontrolled diabetes mellitus
5) Investigator judgement that participation in the study would be difficult due to mental disorders/symptoms
6) Previous thoracic radiotherapy/chemotherapy within the past year
7) Judgement by the surgeon in charge that the patient is not suitable for participation

Related Information

• Primary Sponsor: Okada Morihito
• Source(s) of Monetary Support: Johnson & Johnson K.K.
• Secondary ID(s): UMIN000029562