Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy

Sponsor

Peking University People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04160884

Collaborator

Beijing Municipal Science & Technology Commission (Other)

Enrollment

Location

Arms

29.6

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recently developed fluorescence-navigated thoracoscopy with indocyanine green (ICG) is being used for various kinds of pulmonary surgery, and several studies have reported the application of this novel technique in demarcation of the intersegmental border for segmentectomy. This study is performed prospectively to find out, for the first time, the optimal dosage of ICG in human body to ensure safe and sustained imaging during segmentectomy.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Segmentectomy	Procedure: Indocyanine Green Injection through Peripheral Vein	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy

Actual Study Start Date :

Dec 12, 2018

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A 0.6mg/kg of ICG, iv	Procedure: Indocyanine Green Injection through Peripheral Vein After ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively.
Experimental: B 0.2mg/kg of ICG, iv	Procedure: Indocyanine Green Injection through Peripheral Vein After ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively.

Arm

Intervention/Treatment

Active Comparator: A

0.6mg/kg of ICG, iv

Procedure: Indocyanine Green Injection through Peripheral Vein

After ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively.

Experimental: B

0.2mg/kg of ICG, iv

Procedure: Indocyanine Green Injection through Peripheral Vein

After ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively.

Outcome Measures

Primary Outcome Measures

Signal-to-background Ratio (SBR) of the Targeted and Non-targeted Segments [Surgery]
We use image analysis software ImageJ to evaluate the strength of luminosity in the targeted and non-target segments using intraoperative images and calculate signal-to-background-ratio.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Suitable for segmentectomy and signed informed consent

Exclusion Criteria:

Liver dysfunction.
Allergic to indocyanine green.
Can't tolerate thoracoscopic surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Beijing	China	100044

Sponsors and Collaborators

Peking University People's Hospital
Beijing Municipal Science & Technology Commission

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jun Wang, Chief，Thoracic Surgery Service, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT04160884

Other Study ID Numbers:

2018PHB143-01

First Posted:

Nov 13, 2019

Last Update Posted:

Nov 13, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 13, 2019