NCT04160884

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

1.5 years

First QC Date

November 10, 2019

Last Update Submit

November 12, 2019

Conditions

Pulmonary Segmentectomy

Outcome Measures

Primary Outcomes (1)

  • Signal-to-background Ratio (SBR) of the Targeted and Non-targeted Segments

    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.

    Surgery

Study Arms (2)

A

ACTIVE COMPARATOR

0.6mg/kg of ICG, iv

Procedure: Indocyanine Green Injection through Peripheral Vein

B

EXPERIMENTAL

0.2mg/kg of ICG, iv

Procedure: Indocyanine Green Injection through Peripheral Vein

Interventions

Indocyanine Green Injection through Peripheral VeinPROCEDURE

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

AB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suitable for segmentectomy and signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Central Study Contacts

Feng Yang, MD

CONTACT

(+86) 18612978269yangfeng1007@sina.com

Tiezheng Li, MD

CONTACT

(+86) 18811768786tiezhengli@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief，Thoracic Surgery Service

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 13, 2019

Study Start

December 12, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2021

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

CN(1)