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Trial Title:
Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection
NCT ID:
NCT06344962
Condition:
Suture, Complication
Conditions: Keywords:
Suture
Bronchial Sleeve Resection
Central Primary Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Absorbable Suture
Description:
3-0 V-Loc
Arm group label:
Absorbable Suture Group
Intervention type:
Device
Intervention name:
Non-absorbable Suture
Description:
3-0 Prolene
Arm group label:
Non-absorbable Suture Group
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhe Wu, PhD
Phone:
+86 17863934867
Email:
17863934867@163.com
Start date:
February 28, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06344962
