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A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection

A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection - A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000008301
Enrollment
100
Registered
2012-07-01
Start date
2012-06-01
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

Sponsors

First Department of Surgery, Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients in whom LigaSure may be used during such surgery as pulmonary lobectomy and pulmonary segmentectomy 2)Patients aged 20 years or older 3)Patients scheduled to undergo pulmonary lobectomy and pulmonary segmentectomy 4)Patients with ECOG Performance Status 0 to 1 5)Patients with no history of ipsilateral open lung surgery 6)Patients with preserved major organ function 7)Patients who have provided written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: 1)Patients with a history of chest injury or pulmonary lobectomy 2)Patients with non-curative resectable factors of pulmonary cancer such as pleural dissemination and malignant pleural effusion on opening the chest 3)Patients with active bacterial and/or fungal infections 4)Patients receiving continued systemic (oral or intravenous) steroids 5)Patients with uncontrolled diabetes mellitus (HbA1c > 8.0%) 6)Patients with impaired major organ function (CTCAE ver. 4.0 Grade ≥ 2) 7)Patients with a psychiatric disorder or psychiatric symptoms that would preclude participation in the study 8)Any other patients judged by the doctor in charge to be ineligible as subjects in the study

Design outcomes

Primary

MeasureTime frame
The success rate and results of sealing of pulmonary arteries (under 5 mm in diameter)

Secondary

MeasureTime frame
The frequency of additional procedures to the sealed sites during surgery. The occurrence frequency of intraoperative and postoperative adverse events, the duration of drain placement, and the duration of hospitalization.

Countries

Japan

Outcome results

None listed

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