Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

May 8, 2024 updated by: Yeon Wook Kim, Seoul National University Bundang Hospital

Korean Multicenter 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 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).

Study Type

Observational

Enrollment (Estimated)

1240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yeon Wook Kim, MD., PhD
  • Phone Number: +82-31-787-8134
  • Email: kimyw@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Dongsan Hospital Keimyung University School of Medicine
        • Contact:
          • Sun Hyo Park
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Hallym University Dongtan Sacred Heart Hospital
        • Contact:
          • So Jeong Kim
      • Hwasun, Korea, Republic of
        • Recruiting
        • Chunnam National University Hwasun Hospital
        • Contact:
          • Hyung Joo Oh
      • Ilsan, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
          • Hyung Gu Kang
      • Jinju, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
          • Jong Whan Jeong
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Yeon Wook Kim, MD, PhD
          • Phone Number: +82-31-787-8134
          • Email: kimyw@snu.ac.kr
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center, University of Ulsan College of Medicine
        • Contact:
          • Wonjun Ji
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severence Hospital
        • Contact:
          • Chi Young Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Hostpital
        • Contact:
          • Dong Won Park
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Seoul, Korea
        • Contact:
          • Hyeong Jun Cho
      • Yangsan, Korea, Republic of
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
          • Seong Hoon Yoon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with peripheral pulmonary lesions that require histological differentiation because of the possibility of malignancy and are scheduled for biopsy attempted through guided bronchoscopy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single group
Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy
Device: Guided bronchoscopy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Upon reports of pathologic results (up to 2 weeks after bronchoscopy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity for malignancy
Time Frame: Confirmed by follow-up results at 1 year
True positive/Confirmed malignancy cases
Confirmed by follow-up results at 1 year
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.
Confirmed by follow-up results at 1 year
Complication
Time Frame: Confirmed by follow-up results at 1 year
Evaluate complications due to guided bronchoscopic biopsy
Confirmed by follow-up results at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Yeon Wook Kim, MD., PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K-ORIENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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