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Evaluation of safety and efficacy of staple-line reinforcement in lung resection

Evaluation of safety and efficacy of staple-line reinforcement in lung resection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052220008
Enrollment
48
Registered
2022-04-22
Start date
2022-05-10
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 Lung cancer

Interventions

Patients scheduled for thoracoscopic lobectomy (including robotic-assisted surgery) are eligible. Protocol treatment will be performed after consent is obtained. For patients who meet the selection cr

Sponsors

Tanaka Yugo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 20 years old 2. Patients with a preoper ative PS of 0-1 3. Patients suspected with lung cancer or metastatic lung cancer. 4. Patients scheduled to undergo thoracoscopic surgery including robotic surgery 5. Patients who consented to the study in writing.

Exclusion criteria

Exclusion criteria: (1) Patients who have undergone thoracotomy or thoracoscopic surgery in the past. (2) Patients whom the doctor judged unsuitable as the subject (3) Patient with complete Interlobar fissures of the lung on preoperative CT scan. (4) Patients with pulmonary resection range of 2 or more lobes.

Design outcomes

Primary

MeasureTime frame
Evaluation of air leakage from the staple line on Intraoperative water sealing test

Secondary

MeasureTime frame
(Efficacy endpoints) Pressure resistance, the duration of air leak, air leak location. (Safety endpoints) Occurrence of respiratory complications, illness, and malfunction within 30 days a fter surgery

Contacts

Public ContactSuguru Mitsui

Kobe University Hospital

sugurum@med.kobe-u.ac.jp+81-78-382-5750

Outcome results

None listed

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