Pulmonary SegmentectomyNCT04160884
Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy
A study testing Indocyanine Green Injection through Peripheral Vein in people with Pulmonary Segmentectomy, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Segmentectomy
- What is being tested?
- Indocyanine Green Injection through Peripheral Vein
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable for segmentectomy and signed informed consent
Who cannot join
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Feng Yang, MD, +8618612978269, yangfeng1007@sina.com
About this study
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.
- Conditions
- Pulmonary Segmentectomy
- Being tested
- Indocyanine Green Injection through Peripheral Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green Injection through Peripheral VeinProcedure or surgery
After ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 0.6mg/kg of ICG, iv Receives: Procedure: Indocyanine Green Injection through Peripheral Vein |
| B | Experimental | 0.2mg/kg of ICG, iv Receives: Procedure: Indocyanine Green Injection through Peripheral Vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start12 Dec 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SegmentectomyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160884
- Sponsor's protocol ID
- 2018PHB143-01
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy
- ClinicalTrials.gov ID
- NCT04160884
- Acronym / sponsor ID
- 2018PHB143-01
- Conditions
- Pulmonary Segmentectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Indocyanine Green Injection through Peripheral Vein0.6mg/kg of ICG, iv |
| B | Experimental | Procedure: Indocyanine Green Injection through Peripheral Vein0.2mg/kg of ICG, iv |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suitable for segmentectomy and signed informed consent
Key exclusion criteria (3 listed)
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine Green Injection through Peripheral VeinAfter ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively. | Procedure or surgery | A, B |
Primary outcome
Signal-to-background Ratio (SBR) of the Targeted and Non-targeted Segments
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green Injection through Peripheral Vein in people with Pulmonary Segmentectomy, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Yang, MD ((+86) 18612978269, yangfeng1007@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-background Ratio (SBR) of the Targeted and Non-targeted Segments (time frame: Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.