Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorJiexiong Feng

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children with congenital lung malformations diagnosed by CT or MRI scan

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • atomized inhalation ICG before thoracoscope pneumonectomy

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: ICG for CLMsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

rate residual

Residual lesions can usually only be found in postoperative radiology scan

Time frame
3 months

Secondary outcomes

1

peak volume ratio

Pulmonary function review ventilator-function indicators of peak volume ratio

Time frame
3 months
2

length of hospital stay

length of hospital stay

Time frame
up to 14 days
3

peak time ratio

Pulmonary function review ventilator-function indicators of peak time ratio

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiexiong Feng

Lead sponsor

Tongji Hospital

Sponsor institution