Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions

NCT06701448 | Completed DMC

• 1 other identifier: EC-2022-037 (QX)-02
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the optimal method for Peripheral Pulmonary Lesions (PPL) is uncertain. We aim to compare the diagnostic yield of Robotic Bronchoscopy System (RBS), Electromagnetic Navigation Bronchoscopy (ENB), Fluoroscope-Bronchoscopy (FB).

Conditions

Pulmonary Nodule; Bronchoscopy

Keywords

peripheral pulmonary lesions; optimal strategy; robotic bronchocospy; electromagnetic navigation bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Overall diagnostic yield

  Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.

  1 years after biopsy

Secondary Outcomes (1)

• Strict diagnostic yield

  7 days after biopsy

Study Arms (3)

RBS group

OTHER

Biopsy of peripheral pulmonary lesions using RBS

Diagnostic Test: robotic bronchosopy

ENB group

OTHER

Biopsy of peripheral pulmonary lesions using ENB

Diagnostic Test: Electromagnetic Navigation Bronchoscopy

FB group

OTHER

Biopsy of peripheral pulmonary lesions using FB

Diagnostic Test: Fluoroscopy bronchoscopy

Interventions

robotic bronchosopy DIAGNOSTIC_TEST

robotic bronchoscopy

RBS group

Electromagnetic Navigation Bronchoscopy DIAGNOSTIC_TEST

Electromagnetic Navigation Bronchoscopy

ENB group

Fluoroscopy bronchoscopy DIAGNOSTIC_TEST

Fluoroscopy bronchoscopy

FB group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years, with no gender restrictions;
• Presence of a peripheral lung lesion on chest CT
• Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;
• patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from this study:
• Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \<60×10\^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
• Female patients who are breastfeeding, pregnant, or planning pregnancy;
• Patients with electromagnetic active implantable medical devices;
• Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
• Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
• Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Guangzhou, Guangdong, 510163, China

Location

Related Publications (1)

• Skouras VS, Gkiozos I, Charpidou AG, Syrigos KN. Robotic Bronchoscopy in Lung Cancer Diagnosis. Cancers (Basel). 2024 Mar 17;16(6):1179. doi: 10.3390/cancers16061179.

  PMID: 38539514 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: April 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 25, 2024

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)