Pulmonary Watershed Topographic Map Navigation for Lung Nodule Resection

NCT06404164 | Recruiting DMC

• 1 other identifier: Watershed
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Function Assessment; Disease Free Survival; NSCLC, Stage I

Keywords

Watershed Analysis; wedge resection

Outcome Measures

Primary Outcomes (1)

• Lung fuction

  testing FEV1 and FVC with MIR Spirolab

  1month 3month 1year

Study Arms (1)

Watershed analysis

OTHER

Procedure: Wedge resection under watershed analysis method

Interventions

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

Watershed analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

WenZhao Zhong

CONTACT

+86-13609777314; 13609777314@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 8, 2024
• Study Start: January 30, 2022
• Primary Completion: April 3, 2024
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)