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

JRCT ID: jRCT1052220008

Registered date:22/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 10/05/2022
• Target sample size: 48
• Study type: Interventional

Intervention(s)

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 criteria, the procedure will be performed within 4 weeks after intraoperative lobectomy (upper and lower lobes, upper and middle lobes, upper and lower lobes).
An automatic suture device with staple line reinforcement will be used in interlobar fissures. There is no difference in the use of automatic sutures device with reinforcement between any of the interlobar fissures. In the water seal test, evaluations were performed at applied pressures of 5 cmH2O, 10 cmH2O, 15 cmH2O, and 20 cmH2O. The presence of air leakage from the stapler stump at each pressure and the location of the leakage are evaluated. If air leakage occurs after evaluation, repair is performed and the procedure is terminated. After repair, only the presence of a persistent air leak should be checked. The duration of persistent air leak, duration of chest drain placement, and presence or absence of respiratory complications within 30 days after surgery will be checked and observation will be completed.

Outcome(s)

• Primary Outcome: Evaluation of air leakage from the staple line on Intraoperative water sealing test

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tanaka Yugo