A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge

A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge - A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009813

Enrollment

Registered

2013-01-19

Start date

2013-01-21

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients scheduled to undergo bronchial resection with an linear stapler (Endo GIA Tri-Staple or Endo GIA 2)Patients aged 20 years or older 3)Patients scheduled for lobectomy 4)Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1 5)Patients with healthy organ function 6)Patients who have provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1)Patients who is scheduled right middle lobectomy or suspected invasion or progression of tumors in the lobar bronchi 2) Patients with active bacterial infection or fungal infection 3) Patients receiving continuous systemic administration (oral or intravenous) of steroids 4)Patients with uncontrolled diabetes mellitus (HbA1C>8.0) 5) Any others judged to be ineligible for the study by the investigator

Design outcomes

Primary

Measure	Time frame
Performance of stapling at the bronchial stump of resected tissue (staple formation and alignment, dehiscence, etc.) in lobectomy using the staplers, and the histopathological evaluation (tissue inflammation, bleeding, other reactions, etc.)	—

Countries

Japan

Contacts

Public ContactJiro Okami

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Thoracic Surgery

Outcome results