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NCT Number: NCT05804786

Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions.

The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of emerging technologies.

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Key information

Conditions

Lung Cancer Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongsan Hospital Keimyung University School of Medicine, Daegu, South Korea

Loading trial locations.

About this study

  • Patients with peripheral pulmonary lesions who need histological diagnosis due to suspected lung cancer and whose lesions are judged capable of histological examination through guided bronchoscopy will be prospectively recruited.
  • This study is a pure non-interventional pragmatic design. In addition to biopsy for lung lesions using bronchoscopy, lung cancer staging and tests necessary for metastases and treatment for diagnosed lung cancer are performed according to existing guidelines and the judgment of medical staff.
  • We will analyze the clinical characteristics of guided bronchoscopy procedures used in clinical practice and the main results during the follow-up period of up to one year (diagnostic yield, sensitivity, safety, practicality, and various factors affecting usefulness).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who agreed in writing to participate in this study
  • Adult men and women over 19 years of age
  • Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy
  • Patients capable of biopsy through guided bronchoscopy

Exclusion criteria

  • Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function

Treatment and study plan

Guided bronchoscopy

Device

It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.

Other names: Device: Spin Thoracic Navigation System, Device: Radial EBUS probe

Primary outcomes

  1. Diagnostic yield at index

    Time frame: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)

    The proportion of pathologic results that leads to a specific malignant or benign

Secondary outcomes

  1. Diagnostic accuracy at 12 months

    Time frame: Confirmed by follow-up results at 1 year

    True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures

    Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives.

    For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported.

  2. Sensitivity for malignancy

    Time frame: Confirmed by follow-up results at 1 year

    True positive/Confirmed malignancy cases

  3. Complication

    Time frame: Confirmed by follow-up results at 1 year

    Evaluate complications due to guided bronchoscopic biopsy

Study contacts

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

Yeon Wook Kim, MD., PhD

CONTACT

[email protected]

+82-31-787-8134

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2023
Registry last updated
May 10, 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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