Clinical Efficacy of SIS Staple Line Reinforcement in Preventing Prolong Air Leak After Pulmonary Resection: A Prospective, Multicenter, Randomized Controlled Study (SIS-PALREAL)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600128074

Enrollment

Unknown

Registered

2026-07-14

Start date

2026-07-14

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The diseases covered in this study are: diseases that require lung resection and for which lung resection surgery is planned, including primary bronchogenic lung cancer, lung metastases, etc., all of which are malignant tumors of the lungs

Interventions

Control group:Perform routine anastomosis using a linear stapler

Experimental group:staple line reinforcement

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 years and 80 years inclusive, gender not restricted; 2. Patients who have been determined by the researchers to have indications for lung resection and are scheduled to undergo lung resection surgery; 3. Voluntary participants in this study, capable of following up as required and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of ipsilateral lung surgery within three months; 2. Patients with severe infection or severe pleural adhesions; 3. Patients allergic to collagen or pig-derived materials; 4. Patients with religious beliefs (such as Islam) that prohibit the use of pig-derived implant materials; 5. Patients who cannot understand the trial protocol or complete follow-up due to language or intellectual disabilities; 6. Pregnant or lactating patients, or patients planning to become pregnant during the trial; 7. Patients who have participated in or are currently participating in drug clinical trials within 3 months, or have participated in or are currently participating in other medical device clinical trials within 30 days; 8. Other situations judged by the investigator as not suitable for participation in the trial.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects without PAL occurrence after surgery;	—

Secondary

Measure	Time frame
The number of postoperative air leakage grades;Other postoperative complications;Duration of postoperative air leakage;Time for removal of thoracic drainage tube;Postoperative hospital stay;	—

Countries

China

Contacts

Public ContactGang Feng

Sichuan Provincial People's Hospital

steedvan@163.com+86 28 87393693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026