Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

NCT ID: NCT06302985

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2050-12-31

Brief Summary

To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children.

Detailed Description

Preoperative preparation Preoperative evaluation of pulmonary ventilation function and enhanced CT examination of the lungs were performed. Respiratory symptoms should be improved first in case of complicated respiratory infection. ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery.

Operation method Intraoperative fluorescence thoracoscopic imaging was used, and focal resection was performed. All patients were placed in lateral decubitus position under general anesthesia, and single lung ventilation was selected. A low flow rate (1-2 L/min) and low CO2 pressure (4-5 mmHg) were maintained in the thorax to establish an artificial pneumothorax. The observation hole is in the 7th or 8th intercostal space of the midaxillary line, and the two operating holes are in the 4th or 5th intercostal space of the anterior axillary line and the 8th or 9th intercostal space of the posterior axillary line, respectively. 30 degrees 10 mm fluorescence thoracoscope. After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed. Smaller blood vessels could be cut by Ligasure or ultrasonic knife directly, and thicker blood vessels and bronchi should be cut by Hemolock until the lesion resection was completed. After the lesion was removed, the chest was rinsed with warm normal saline, and the lung tissue section was carefully examined to confirm that there was no active bleeding and air leakage, and the lung was well dilated. The intercostal nerve was blocked under thoracoscopic vision. Finally, the thoracic closed drainage tube was placed in the midaxillary line puncture hole and the incision was closed.

Post-operation follow-up All patients undergo outpatient follow-up 3-6 months after surgery, including pulmonary CT and pulmonary ventilation function measurements, and comparison of VT (tidal volume), Ti/Te suction/exhalation time ratio, TPTEF/TE (peak time ratio) and VPEF/VE (peak volume ratio) before and after surgery.

Conditions

Pulmonary Sequestration; Congenital Pulmonary Airway Malformation; Indocyanine Green; Thoracoscopic Surgery; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICG for CLMs

Preoperative preparation ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery.

Operation method After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed. Smaller blood vessels could be cut by Ligasure or ultrasonic knife directly, and thicker blood vessels and bronchi should be cut by Hemolock until the lesion resection was completed.

Group Type: EXPERIMENTAL

atomized inhalation ICG before thoracoscope pneumonectomy

Intervention Type: PROCEDURE

Preoperative preparation ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery.

Operation method After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed.

Interventions

atomized inhalation ICG before thoracoscope pneumonectomy

Preoperative preparation ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery.

Operation method After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• children with congenital lung malformations diagnosed by CT or MRI scan

Exclusion Criteria

• 1. ages <3 months and >14 years 2. complicated other life-threatening disease; 3. complicated severely pulmonary infection

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiexiong Feng

OTHER

Sponsor Role: lead

Responsible Party

Jiexiong Feng

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tianqi Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tianqi Zhu, MD

Role: CONTACT

zhutianqi84@163.com

0086-13986295423 ext. 430000

Facility Contacts

Tianqi Zhu, MD PhD

Role: primary

zhutianqi84@163.com

13986295423

Other Identifiers

ICG-CLMs

Identifier Type: -

Identifier Source: org_study_id