Pulmonary Watershed Topographic Map Navigation for Lung Nodule Resection

NCT ID: NCT06404164

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2027-12-30

Brief Summary

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

Detailed Description

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1. 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;
2. 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.
3. 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.

Conditions

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Pulmonary Function Assessment Disease Free Survival NSCLC, Stage I

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Watershed analysis

Group Type OTHER

Wedge resection under watershed analysis method

Intervention Type 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

Interventions

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Wedge resection under watershed analysis method

* 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. \<1cm CTR≤0.75; \<1.5cm CTR≤0.5; \<2cm CTR≤0.25 Lung nodules
2. The tumor center is located in the peripheral 2/3 area of the lung field
3. Preoperative analysis and planning of watershed by 3D reconstruction
4. Clinically assessed as cT1aN0M0 stage IA1/cT1bN0M0 stage IA2 (eighth edition), clinically resectable

Exclusion Criteria

1. No surgical video, no postoperative gross specimen and related distance measurement records
2. The incision edge does not exceed the target nodule diameter from the nodule edge
3. The resection range exceeds 50% of the preoperative planning
4. Postoperative pathological staging non-pT1aN0M0 IA1 stage/pT1bN0M0 IA2 stage (eighth edition)
5. Any situation where the investigator feels the need for extended resection
6. 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-zhao ZHONG

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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WenZhao Zhong

Role: CONTACT

+86-13609777314

Facility Contacts

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Wen-Zhao Zhong

Role: primary

+86-13609777314

Other Identifiers

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Watershed

Identifier Type: -

Identifier Source: org_study_id

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