Methods of Establishing Intersegmental Plane in Segmentectomy

Surgery Clinical Trial

Official title:

Methods of Establishing Intersegmental Plane in Segmentectomy: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015399
• Other study ID #: LYF2023098
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2026

Study information

• Verified date: August 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: Yan Hu, M.D., Ph.D.
• Phone: +8685296122
• Email: yanhu[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.

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 into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients voluntarily join and sign a written informed consent;

2. The age of the subjects is 18-75 years old, regardless of gender;

3. The ECOG PS was 0 or 1;

4. 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;

5. Thin-slice CT suggests any of the following: ? The diameter of pulmonary nodules is 2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ? Pulmonary nodule diameter =2cm and 0.25 < CTR < 0.5; ? Non-peripheral pulmonary nodule diameter =2cm and CTR=0.25;

6. cN0 and no distant metastasis;

7. Intraoperative freezing examination or postoperative paraffin examination suggest early lung adenocarcinoma;

8. Intraoperative freezing disease of station 12 lymph nodes showed no cancer metastasis;

9. Preoperative anesthesia risk assessment: American Society of Anesthesiologists (ASA) Level I-III;

10. Has no history of lung resection;

11. Has not received anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy and immunotherapy.

Exclusion Criteria:

1. The subject did not understand the study protocol, did not cooperate or refused to sign the informed consent;

2. The subject has a history of malignant tumor or has previously received anti-tumor therapy;

3. 3D visualization was not received before surgery;

4. The surgeon judged that segmentectomy could not ensure complete resection of the tumor;

5. has a history of lung resection, or chest trauma or surgery on the affected side of chest cavity;

6. Extensive intraoperative dense thoracic adhesion;

7. Conversion to thoracotomy;

8. Intraoperative frozen examination of intrapulmonary lymph nodes indicated cancer metastasis;

9. Pulmonary nodules are located in the right middle lung;

10. Suffered from chronic bronchitis, emphysema, asthma and other chronic lung diseases;

11. Other conditions unsuitable for inclusion in this study deemed by the researcher.

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• Implementation of closed insufflation technique during segmentectomy
After the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device.
• Implementation of dilatation and collapse technique during segmentectomy
Divide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes).

Locations

Country	Name	City	State
China	Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intersegmental plane clarity grading	Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane.	intraoperatively
Primary	Surgical complications	Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.	Up to 3 months
Primary	Operative time required for segmentectomy	Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy.	From the dissection of segmental structures to finish of segementectomy
Primary	Pulmonary function 3 months and 1 year after surgery	Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery.	Up to 1 year
Secondary	Intraoperative blood loss	Intraoperative blood loss will be measured as the total volume of blood loss during the operation.	Intraoperatively
Secondary	Postoperative hospital stay	Postoperative hospital stay will be measured as the number of days between surgery and discharge.	Up to 2 weeks
Secondary	Days of chest tube placement	Days of chest tube placement will be measured as the number of days between surgery and chest tube pull-out.	Up to 2 weeks
Secondary	Safety margin	Minimum distance between nodule and every margin can be measured preoperatively by 3D reconstruction tool and intraoperatively by ruler after the targetd segment has been resected.	Up to 1 week
Secondary	Volume of targeted parenchymal tissue	Volume of targeted parenchymal tissue will be calculated by 3D reconstruction tool.	Up to 3 days