JRCT ID: jRCTs062250047
Registered date:27/08/2025
SLR Trial
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Primary lung cancer, metastatic lung tumor, benign lung tumor, pneumothorax, etc. |
| Date of first enrollment | 09/09/2025 |
| Target sample size | 140 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | SLR use or non-use |
Outcome(s)
| Primary Outcome | The incidence of air leaks from the staple line during the intraoperative water-sealing test |
|---|---|
| Secondary Outcome | (1) The incidence of air leaks at different pressure levels (2) Duration of air leaks (3) Location of air leaks (4) Duration of chest drain placement (5) Presence of respiratory complications within 30 days postoperatively (6) Presence of adverse events (7) Economic impact |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients who meet all of the following criteria will be included: (1) Patients scheduled to undergo thoracoscopic pulmonary sublobar resection (wedge resection or segmentectomy) using an automatic stapler. * Thoracoscopic surgery includes robot-assisted thoracoscopic surgery. (2) Patients who have provided written informed consent for participation in this study. |
| Exclude criteria | **Exclusion Criteria for Initial Registration** Patients meeting any of the following criteria will be excluded from this clinical study: (1) Patients suspected of having severe intrathoracic adhesions (e.g., history of empyema, tuberculosis, or ipsilateral reoperation). (2) Patients deemed unsuitable as subjects by the principal investigator or sub-investigators. (3) Patients undergoing pulmonary resection at three or more sites simultaneously. **Exclusion Criteria for Secondary Registration** Patients meeting the following criterion will not proceed to secondary registration: (1) Patients for whom thoracoscopic surgery or the use of an automatic stapler was discontinued due to severe intrathoracic adhesions or other reasons. |
Related Information
| Primary Sponsor | Tanaka Yugo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Shinji Matsui |
| Address | 36-1, Nishi-cho, Yonago, Tottori, Japan Tottori Japan 683-8504 |
| Telephone | +81-859-38-6737 |
| s-matsui@tottori-u.ac.jp | |
| Affiliation | Tottori University Hospital |
| Scientific contact | |
| Name | Yugo Tanaka |
| Address | 36-1, Nishi-cho, Yonago, Tottori, Japan Tottori Japan 683-8504 |
| Telephone | +81-859-38-6737 |
| tanakay@tottori-u.ac.jp | |
| Affiliation | Tottori University Hospital |