Status:
NOT_YET_RECRUITING
Methods of Establishing Intersegmental Plane in Segmentectomy
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in s...
Detailed Description
This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided in...
Eligibility Criteria
Inclusion
- Patients voluntarily join and sign a written informed consent;
- The age of the subjects is 18-75 years old, regardless of gender;
- The ECOG PS was 0 or 1;
- Three-dimensional visualization was performed before surgery, and the surgeon judged that the tumor could be completely removed by segmentectomy, and surgical margin was expected to be greater than 2cm or the maximum diameter of the nodule;
- Thin-slice CT suggests any of the following: ① The diameter of pulmonary nodules is 2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ② Pulmonary nodule diameter ≤2cm and 0.25 \< CTR \< 0.5; ③ Non-peripheral pulmonary nodule diameter ≤2cm and CTR≤0.25;
- cN0 and no distant metastasis;
- Intraoperative freezing examination or postoperative paraffin examination suggest early lung adenocarcinoma;
- Intraoperative freezing disease of station 12 lymph nodes showed no cancer metastasis;
- Preoperative anesthesia risk assessment: American Society of Anesthesiologists (ASA) Level I-III;
- Has no history of lung resection;
- Has not received anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy and immunotherapy.
Exclusion
- The subject did not understand the study protocol, did not cooperate or refused to sign the informed consent;
- The subject has a history of malignant tumor or has previously received anti-tumor therapy;
- 3D visualization was not received before surgery;
- The surgeon judged that segmentectomy could not ensure complete resection of the tumor;
- has a history of lung resection, or chest trauma or surgery on the affected side of chest cavity;
- Extensive intraoperative dense thoracic adhesion;
- Conversion to thoracotomy;
- Intraoperative frozen examination of intrapulmonary lymph nodes indicated cancer metastasis;
- Pulmonary nodules are located in the right middle lung;
- Suffered from chronic bronchitis, emphysema, asthma and other chronic lung diseases;
- Other conditions unsuitable for inclusion in this study deemed by the researcher.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06015399
Start Date
September 1 2023
End Date
March 1 2026
Last Update
August 29 2023
Active Locations (1)
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1
Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
Changsha, Hunan, China, 410011