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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Suture, Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Absorbable Suture Group

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.

Group Type EXPERIMENTAL

Absorbable Suture

Intervention Type DEVICE

3-0 V-Loc

Non-absorbable Suture Group

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.

Group Type EXPERIMENTAL

Non-absorbable Suture

Intervention Type DEVICE

3-0 Prolene

Interventions

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Absorbable Suture

3-0 V-Loc

Intervention Type DEVICE

Non-absorbable Suture

3-0 Prolene

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No