A Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resection

A Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resection - Trial of Evaluating of Air Leakage using Staple Line Reinforcements

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032220620

Enrollment

120

Registered

2023-02-09

Start date

2023-02-09

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

Diseases requiring anatomical lobectomy or segmentectomy in thoracic surgery

Interventions

1) Eligible and consenting patients will be pre-assigned to use or not use staple line reinforcements in the automated suturing devise. 2) Intraoperative air leakage will be evaluated at and the stapl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 18 to 90 years of age 2) Anatomical pulmonary resection (lobectomy or segmentectomy) using an automated suturing device is planned. 3) Patient is considered to have lobar insufficiency on preoperative chest CT and is considered to require an automated suturing device for pulmonary resection. 4) ECOG performance status (PS) is 0-1. 5) Main organ function is preserved. 6) The patient's consent to participate in this study has been obtained in writing.

Exclusion criteria

Exclusion criteria: 1) Wedge resection. 2) Patient with multiple lobectomy or segmentectomy that will not result in en bloc resection. 3) Patient who is considered to be completely lobulated on preoperative chest CT and is considered not to require an automated suturing device for pulmonary resection. 4) Patient with dementia or other conditions that require consent from legally authorized representative 5) Patients who may exhibit allergic reactions to the device to be used. 6) Patients deemed by the investigator to be unsuitable for the safe conduct of this study

Design outcomes

Primary

Measure	Time frame
Intraoperative air leakage from staple line and its vicinity in anatomic pulmonary resection using an automated suturing device with staple line reinforcement.	—

Secondary

Measure	Time frame
1) Time required to repair intraoperative air leakage. 2) Duration of postoperative chest drainage tube placement. 3) Evaluate the presence or absence of additional procedures. 4) Evaluate presence of delayed air leakage. 5) Evaluate intraoperative and postoperative air leakage due to different automated suturing devices. 6) Evaluate intraoperative air leakage,postoperative air leakage or delayed air leakage due to surgical procedures. 7) Number of automated suturing devices used for pulmonary resection.	—

Measure

Time frame

1) Time required to repair intraoperative air leakage. 2) Duration of postoperative chest drainage tube placement. 3) Evaluate the presence or absence of additional procedures. 4) Evaluate presence of delayed air leakage. 5) Evaluate intraoperative and postoperative air leakage due to different automated suturing devices. 6) Evaluate intraoperative air leakage,postoperative air leakage or delayed air leakage due to surgical procedures. 7) Number of automated suturing devices used for pulmonary resection.

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Contacts

Public ContactJotaro Yusa

Chiba University Hospital

ccwa4980@chiba-u.jp+81-43-226-2547

Outcome results

None listed

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