Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy

June 7, 2024 updated by: Yeon Wook Kim, Seoul National University Bundang Hospital

Comparison and Synergistic Evaluation of Needle Aspiration and Forceps Biopsy for Diagnosis of Lung Lesions With Electromagnetic Navigation Bronchoscopy

This randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative yield and discordance between the two devices.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized crossover study aimed to evaluate whether combining electromagnetic navigation bronchoscopy (ENB)-guided needle aspiration and forceps biopsy provides synergistic benefits, and compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions.

The investigators designed this study to prospectively enroll patients with lung lesions that warrant histologic diagnosis and are feasible for undergoing electromagnetic bronchoscopy under moderate sedation. Participants will be randomized to two groups. One group will receive an ENB-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-first group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-first group). All participants will undergo ENB under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy and radial endobronchial sonography. All participants will be followed up for up to 12 months to confirm the final diagnosis.

The primary endpoint is the diagnostic accuracy of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with forceps biopsy alone. Diagnostic accuracy was defined as the proportion of participants in whom the biopsy yielded a definitive diagnosis, consistent with the strict definition; a biopsy procedure was considered diagnostic if the specimen established a definitive malignancy (true positive) or a specific benign diagnosis that sufficiently represented the lesion and informed further management (true negative) without the change in diagnosis through 12 months of follow-up.

Secondary endpoints include diagnostic accuracy of the combination compared with needle aspiration alone, sensitivity for malignancy, and the strictly defined diagnostic yield determined solely based on the ENB procedural encounter, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the ENB procedure.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

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

Description

Inclusion Criteria:

  • Patients with lung lesions with a possibility of malignancy and need tissue confirmation, which is eligible for ENB procedure under moderate sedation

Exclusion Criteria:

  • Patients who disagree to participate

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Needle-first
Participants affiliated to this arm will undergo ENB-guided biopsy with needle aspiration first, followed by forceps biopsy
Device: Device for performing biopsy via electromagnetic navigation bronchoscopy
Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)
Active Comparator: Forceps-first
Participants affiliated to this arm will undergo ENB-guided biopsy with forceps first, followed by needle aspiration.
Device: Device for performing biopsy via electromagnetic navigation bronchoscopy
Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conservative diagnostic accuracy at 12 months
Time Frame: Confirmed by follow-up results at 12 months
([True positive + True negative]/All biopsied performed)
Confirmed by follow-up results at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of needle or forceps biopsy for diagnosis of malignancy
Time Frame: Confirmed by follow-up results at 12 months
True positive/Confirmed malignancy cases
Confirmed by follow-up results at 12 months
Duration of procedure
Time Frame: At index procedure
Total duration and time per sampling for needle and forceps biopsy
At index procedure
Diagnostic yield at index procedure
Time Frame: At index procedure
The proportion of pathologic results that leads to a specific malignant or benign diagnosis
At index procedure

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)

December 1, 2021

Primary Completion (Actual)

November 13, 2023

Study Completion (Estimated)

November 13, 2024

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONFIDENT_ENB

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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