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Recruiting

NCT Number: NCT06404164

Pulmonary Watershed Topographic Map Navigation for Lung Nodule Resection

A method of ICG counterstaining localization under target artery occlusion without cutting,It's a new method of localization of small pulmonary nodules.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Wen-Zhao Zhong

CONTACT

[email protected]

+86-13609777314

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <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

Exclusion criteria

  • 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

Treatment and study plan

Wedge resection under watershed analysis method

Procedure
  • 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

Primary outcomes

  1. Lung fuction

    Time frame: 1month 3month 1year

    testing FEV1 and FVC with MIR Spirolab

Study contacts

Contact information is provided by the study sponsor or research team.

WenZhao Zhong

CONTACT

[email protected]

+86-13609777314

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

Artificial Intelligence Pulmonary Watershed Terrain Navigation System for Lung Nodule Localization and Lung Function Preservation

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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