Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi

Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi - Feasibility study of the safety and usefulness of an endo-stapler (Powered ECHELON FLEX 7) in the manipulation of segmental and middle lobe bronchi

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029562

Enrollment

Registered

2017-10-16

Start date

2017-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

During surgical procedure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients likely to undergo segmental resection (2 segments or less) or middle lobe resection 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

Exclusion criteria

Exclusion criteria: 1) Patients likely to undergo 3 segmental resections all together, such as basal 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

Design outcomes

Primary

Measure	Time frame
Incidence of bronchopleural fistula events within one month after pulmonary resection.	—

Secondary

Measure	Time frame
Incidence of postoperative complications	—

Countries

Japan

Contacts

Public ContactYoshihiro Miyata

Hiroshima University Hospital Surgical Oncology

ymiyata@hiroshima-u.ac.jp082-257-5869

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026