Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection

Suture, Complication Clinical Trial

Official title:

Comparison of Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344962
• Other study ID #: QYFYKYLL930611921
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: The Affiliated Hospital of Qingdao University
• Contact: Zhe Wu, PhD
• Phone: +86 17863934867
• Email: 17863934867[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.

Description:

Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Although the treatment of lung cancer is increasingly diverse, surgical resection is still the mainstay.

Pneumonectomy, as a surgical approach for central primary lung cancer, is very harmful to patients. Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. Both absorbable and non-absorbable suture are used for it. But there are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem.

The investigator sets incidence rate of anastomotic complications as the primary endpoint. According to the calculation, a total of 40 patients will be enrolled (each group has 20 patients).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 75 years old.

2. The tumor is located in the opening of bronchus, or the edge of the tumor is less than 2 cm away from the opening of the bronchi, while the distance between the edge of the tumor and the carina is more than 1.5 cm.

3. Patients with pathological diagnosis of non-small cell lung cancer.

4. No distant metastasis in preoperative clinical evaluation.

5. Adequate cardiac function, pulmonary function, liver function and renal function for anesthesia and bronchial sleeve resection.

6. American Society of Anesthesiologists (ASA) score: Grade I-III.

7. Patients who can coordinate the treatment and research and sign the informed consent.

Exclusion Criteria:

1. Patients with a significant medical condition which is thought unlikely to tolerate the surgery or unsuitable for this study after the evaluation of the investigator.

2. Patients with psychiatric disease who are expected lack of compliance with the protocol.

Related Conditions & MeSH terms

• Suture, Complication

Intervention

Device:
• Absorbable Suture
3-0 V-Loc
• Non-absorbable Suture
3-0 Prolene

Locations

Country	Name	City	State
China	the Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of anastomotic complications	such as anastomotic stenosis, anastomotic fistula and so on	12 months after surgery
Secondary	Time of bronchial anastomosis	From the first stitch to the last stitch	During surgery
Secondary	Number of stitches	During bronchial anastomosis	During surgery
Secondary	5-year survival rate	Follow up for 5 years	5 years after surgery