Methods of Establishing Intersegmental Plane in Segmentectomy

NCT06015399 | Not Yet Recruiting

• 1 other identifier: LYF2023098
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Surgery

Keywords

segmentectomy; intersegmental plane; closed insufflation technique; dilatation and collapse technique; randomized controlled study

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Intraoperative blood loss

  Intraoperatively

• Postoperative hospital stay

  Up to 2 weeks

• Days of chest tube placement

  Up to 2 weeks

• Safety margin

  Up to 1 week

• Volume of targeted parenchymal tissue

  Up to 3 days

Study Arms (2)

Closed insufflation technique group

EXPERIMENTAL

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

Dilatation and collapse technique

ACTIVE COMPARATOR

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

Interventions

Implementation of closed insufflation technique during segmentectomy PROCEDURE

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.

Closed insufflation technique group

Implementation of dilatation and collapse technique during segmentectomy PROCEDURE

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).

Dilatation and collapse technique

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• D 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;

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yan Hu, M.D., Ph.D.

CONTACT

+8685296122; yanhu@csu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 29, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

CN (1)