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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suture, Complication
• Intervention / Treatment: Device: Absorbable Suture; Device: Non-absorbable Suture

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Wu, PhD; Phone Number: +86 17863934867; Email: 17863934867@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The affiliated hospital of Qingdao university
      • Contact: Zhe Wu, PhD; Phone Number: +86 17863934867; Email: 17863934867@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Absorbable Suture; 3-0 V-Loc
Experimental: 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.	Device: Non-absorbable Suture; 3-0 Prolene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of anastomotic complications	such as anastomotic stenosis, anastomotic fistula and so on	12 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: Wenjie Jiao, PhD, The affiliated hospital of Qingdao university

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Suture; Non-Small Cell Lung Cancer (NSCLC); Bronchial Sleeve Resection; Central Primary Lung Cancer
• Other Study ID Numbers: QYFYKYLL930611921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No