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

Not Applicable

Recruiting

• Conditions: Suture, Complication
• Interventions: Device: Non-absorbable Suture; Device: Absorbable Suture

• Registration Number: NCT06344962
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2023-02-28
• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-absorbable Suture Group	Non-absorbable Suture	All enrolled patients will accept bronchial sleeve resection and lymphadenectomy. If fast-frozen pathology of the resection margin of bronchus confirms negative, We will use the non-absorbable sutures for bronchial anastomosis.
Absorbable Suture Group	Absorbable Suture	All enrolled patients will accept bronchial sleeve resection and lymphadenectomy. If fast-frozen pathology of the resection margin of bronchus confirms negative, We will use the absorbable sutures for bronchial anastomosis.

Primary Outcome Measures

Name	Time	Method
Incidence rate of anastomotic complications	12 months after surgery	such as anastomotic stenosis, anastomotic fistula and so on

Secondary Outcome Measures

Name	Time	Method
Time of bronchial anastomosis	During surgery	From the first stitch to the last stitch
Number of stitches	During surgery	During bronchial anastomosis
5-year survival rate	5 years after surgery	Follow up for 5 years

Trial Locations

Locations (1)

the Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China