Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.

The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.

A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

GS-TBLB-X-ray

Jiayuan Sun, MD

The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .

The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope department, Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University, China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray group.Each subject will be randomized to each group.The study is expected to enroll 60 patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).

ENB-GS-TBLB for the Diagnosis of PPLs

Diagnostic Value of Electromagnetic Navigation Bronchoscopy With a Guide Sheath for Peripheral Pulmonary Lesions : a Randomized Controlled Trial

The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.

Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.

Fudan University

Shanghai Chest Hospital

Director, Endoscope Center, Shanghai Chest Hospita

The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.

GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

ENB-GS-TBLB-X-ray Group

The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

GS-TBLB-X-ray Group

Total

Age, Continuous

Sex: Female, Male

lesion size(long axis)

lesion size(short axis)

Upper Lobes

Middle Lobes

Lower lobes

lesion location

distance of the nodule to the pleural surface

distance from the lesion to the pleural

The bronchus sign on CT represents the presence of a bronchus leading directly to a peripheral pulmonary lesion.

bronchus sign

Dr. Jiayuan Sun

Diagnosed by TBLB

Not Diagnosed by TBLB

The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB

Total procedure time

Total X-ray time

Duration time for finding lesion

X-ray time for finding lesion

The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone

The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.

ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.

GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s).

Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.

Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.

Faiz Bhora, MD

The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.

The Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes (PLOTS) registry is aimed at developing a high quality set of data regarding intraoperative percutaneous localization of peripheral pulmonary nodules (PPNs), and then identifying and promulgating efficient, evidence-based best practices for this technique. The resection procedure itself is standard of care and follows the investigator's standard protocol.

Successful localization of PPNs is a challenge involving multiple factors, beginning with the subjects' health, lung function and also factors specific to the nodule including location within the lung, size, distance from the lung surface, whether solid or ground glass and proximity to a fissure. Hard to see or palpate nodules are currently localized with dye and/or hook wires or fiducials, either endoscopically or percutaneously. Successful, large, prospective studies have not been reported using modern electro-magnetic navigation (EMN)-guided percutaneous intraoperative localization, and different techniques (dye vs. fiducial vs. hook wire etc.) have not been broadly evaluated. It is for these reasons that the different localization techniques used with EMN-guided percutaneous localization will be collected for patients having a suspicious nodule and who undergo percutaneous intra-operative localization and immediate resection.

This registry aims to record the localization techniques used by thoracic surgeons and IP/surgical teams to identify PPNs using the SPiN Thoracic Navigation System™ in the hands of trained physicians. The objectives of this study will be to accomplish the primary and secondary objectives listed below, and to observe localization in a real world context of pulmonary resection.

Percutaneous Localization: Open-label Registry of Thoracic Surgery

Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.

Successful percutaneous localization of PPN defined as the percentage of subjects in whom the nodule is successfully localized and removed in the first resected specimen.

Safety data, including instances of adverse events and device deficiencies, will be collected.

Details regarding the localization technique will be collected, including the materials used. If dye (methylene blue, ICG etc.) is used the volume will be collected. Other materials include microcoils, hook wires, etc..

The time of the localization procedure will be recorded. The length of the entire surgical procedure will also be recorded.

Details regarding nodule characteristics - solid, semisolid, groundglass; location in relation to anatomical markers and position; size; presence of spiculation - will be collected.

The weight (in grams) of excised tissue will be recorded, as well as the measurement of the included margin.

The surgical resection may include segmentectomy or wedge using the VATS, RATS, or thoracotomy techniques.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ENB-GS-TBLB for the Diagnosis of PPLs	NCT02207478	Lung Cancer	ENB GS-TBLB-X-ray	18 Years - 80 Years	Shanghai Chest Hospital
Percutaneous Localization: Open-label Registry of Thoracic Surgery	NCT04066699	Lung Lesion(s) ... Pulmonary Metas... Pulmonary Nodul... Peripheral Lung...	Percutaneous lo...	18 Years -	Veran Medical Technologies
Percutaneous Localization: Open-label Registry of Thoracic Surgery	NCT04066699	Lung Lesion(s) ... Pulmonary Metas... Pulmonary Nodul... Peripheral Lung...	Percutaneous lo...	18 Years -	Veran Medical Technologies

Spots Global Cancer Trial Database for peripheral lung lesions