Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

NCT06302985 | Recruiting

• 1 other identifier: ICG-CLMs
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• rate residual

  Residual lesions can usually only be found in postoperative radiology scan

  3 months

Secondary Outcomes (3)

• peak volume ratio

  3 months

• length of hospital stay

  up to 14 days

• peak time ratio

  3 months

Study Arms (1)

ICG for CLMs

EXPERIMENTAL

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.

Procedure: atomized inhalation ICG before thoracoscope pneumonectomy

Interventions

atomized inhalation ICG before thoracoscope pneumonectomy 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.

ICG for CLMs

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiexiong Feng: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Sequestration; Cystic Adenomatoid Malformation of Lung, Congenital

Condition Hierarchy (Ancestors)

Respiratory System Abnormalities; Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases

Study Officials

• Tianqi Zhu, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianqi Zhu, MD

CONTACT

0086-13986295423; zhutianqi84@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

CN (1)