Methods of Establishing Intersegmental Plane in Segmentectomy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery
• Intervention / Treatment: Procedure: Implementation of closed insufflation technique during segmentectomy; Procedure: Implementation of dilatation and collapse technique during segmentectomy

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Hu, M.D., Ph.D.; Phone Number: +8685296122; Email: yanhu@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China

Participation Criteria

Eligibility Criteria

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

Description

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: 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;
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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closed insufflation technique group; Closed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique.	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.
Active Comparator: Dilatation and collapse technique; Dilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique.	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Surgical complications	Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.	Up to 3 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss will be measured as the total volume of blood loss during the operation.	Intraoperatively
Postoperative hospital stay	Postoperative hospital stay will be measured as the number of days between surgery and discharge.	Up to 2 weeks
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
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
Volume of targeted parenchymal tissue	Volume of targeted parenchymal tissue will be calculated by 3D reconstruction tool.	Up to 3 days

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: segmentectomy; randomized controlled study; intersegmental plane; closed insufflation technique; dilatation and collapse technique
• Other Study ID Numbers: LYF2023098

Drug and device information, study documents

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