Pulmonary Function AssessmentNCT06404164
Pulmonary Watershed Topographic Map Navigation for Lung Nodule Resection
A study testing Wedge resection under watershed analysis method in people with Pulmonary Function Assessment and Disease Free Survival, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
A method of ICG counterstaining localization under target artery occlusion without cutting，It's a new method of localization of small pulmonary nodules. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Function Assessment, Disease Free Survival, NSCLC, Stage I
- What is being tested?
- Wedge resection under watershed analysis method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 30 Dec 2027
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- <1cm CTR≤0.75; <1.5cm CTR≤0.5; <2cm CTR≤0.25 Lung nodules
- The tumor center is located in the peripheral 2/3 area of the lung field
- Preoperative analysis and planning of watershed by 3D reconstruction
- Clinically assessed as cT1aN0M0 stage IA1/cT1bN0M0 stage IA2 (eighth edition), clinically resectable
Who cannot join
- No surgical video, no postoperative gross specimen and related distance measurement records
- The incision edge does not exceed the target nodule diameter from the nodule edge
- The resection range exceeds 50% of the preoperative planning
- Postoperative pathological staging non-pT1aN0M0 IA1 stage/pT1bN0M0 IA2 stage (eighth edition)
- Any situation where the investigator feels the need for extended resection
- Patients with chronic diseases (such as COPD, pulmonary fibrosis, silicosis) that can cause loss of lung function in patients at risk of progression or potential progression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Wen-Zhao Zhong, +86-13609777314, 13609777314@163.com
About this study
Official title: Artificial Intelligence Pulmonary Watershed Terrain Navigation System for Lung Nodule Localization and Lung Function Preservation
A method of ICG counterstaining localization under target artery occlusion without cutting，It's a new method of localization of small pulmonary nodules.
Read the detailed description
- This technology can replace part of CT puncture-guided positioning, which not only saves CT positioning costs for patients, but also saves time and space resources in CT room;
- The target artery occlusion technique does not cut off the blood vessels, and the operation is still a wedge resection. Compared with the standard segmentectomy/subsegmentectomy, the steps of cutting off the veins and bronchial tubes are reduced, the operation time is shortened, and the turnover rate is improved.
- There is less damage to the lung tissue, and the lung function is well preserved. The patients can be discharged in an average of 3 days after the operation, which improves the bed turnover efficiency of the department.
- Being tested
- Wedge resection under watershed analysis method
- Keywords
- Watershed Analysis, wedge resection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wedge resection under watershed analysis methodProcedure or surgery
- Compare the preoperative 3D reconstruction model, and use electrocautery to directionally separate and expose the target artery;
- Auxiliary devices (unlimited) to block the target artery, but should not be severed; ③ Peripheral intravenous injection of ICG, electrocautery to mark the border of counter-staining; ④ Evaluate the actual incisal margin according to the preoperative planning, and use the cutting stapler to wedge resection of the pulmonary nodule
| Study group | Role | What they receive |
|---|---|---|
| Watershed analysis | Other | Not described Receives: Procedure: Wedge resection under watershed analysis method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung fuction
testing FEV1 and FVC with MIR Spirolab
Measured: 1month 3month 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Jan 2022
- Primary completion3 Apr 2024
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Function AssessmentStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404164
- Sponsor's protocol ID
- Watershed
- Status last verified
- May 2024
- First submitted
- 27 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No