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

NCT06344962 | Recruiting DMC

• 1 other identifier: QYFYKYLL930611921
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Suture, Complication

Keywords

Suture; Bronchial Sleeve Resection; Central Primary Lung Cancer; Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Incidence rate of anastomotic complications

  such as anastomotic stenosis, anastomotic fistula and so on

  12 months after surgery

Secondary Outcomes (3)

• Time of bronchial anastomosis

  During surgery

• Number of stitches

  During surgery

• 5-year survival rate

  5 years after surgery

Study Arms (2)

Absorbable Suture Group

EXPERIMENTAL

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

Non-absorbable Suture Group

EXPERIMENTAL

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

Interventions

Absorbable Suture DEVICE

3-0 V-Loc

Absorbable Suture Group

Non-absorbable Suture DEVICE

3-0 Prolene

Non-absorbable Suture Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old.
• 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.
• Patients with pathological diagnosis of non-small cell lung cancer.
• No distant metastasis in preoperative clinical evaluation.
• Adequate cardiac function, pulmonary function, liver function and renal function for anesthesia and bronchial sleeve resection.
• American Society of Anesthesiologists (ASA) score: Grade I-III.
• Patients who can coordinate the treatment and research and sign the informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wenjie Jiao, PhD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Wu, PhD

CONTACT

+86 17863934867; 17863934867@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: February 28, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)