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

NCT05110131 | Active Not Recruiting

• 1 other identifier: CONFIDENT_ENB
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Lung Cancer (Diagnosis)

Keywords

Electromagnetic Navigation Bronchoscopy; Bronchoscopy; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Conservative diagnostic accuracy at 12 months

  (\[True positive + True negative\]/All biopsied performed)

  Confirmed by follow-up results at 12 months

Secondary Outcomes (3)

• Sensitivity of needle or forceps biopsy for diagnosis of malignancy

  Confirmed by follow-up results at 12 months

• Diagnostic yield at index procedure

  At index procedure

• Duration of procedure

  At index procedure

Study Arms (2)

Needle-first

ACTIVE COMPARATOR

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

Forceps-first

ACTIVE COMPARATOR

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

Interventions

Device for performing biopsy via electromagnetic navigation bronchoscopy DEVICE

Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)

Forceps-first; Needle-first

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients who disagree to participate

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (8)

• Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, Minnich DJ, Bansal S, Ellis BQ, Mahajan AK, Gildea TR, Bechara RI, Sztejman E, Flandes J, Rickman OB, Benzaquen S, Hogarth DK, Linden PA, Wahidi MM, Mattingley JS, Hood KL, Lin H, Wolvers JJ, Khandhar SJ; NAVIGATE Study Investigators. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019 Mar;14(3):445-458. doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.

  PMID: 30476574 BACKGROUND

• Vachani A, Maldonado F, Laxmanan B, Kalsekar I, Murgu S. The Impact of Alternative Approaches to Diagnostic Yield Calculation in Studies of Bronchoscopy. Chest. 2022 May;161(5):1426-1428. doi: 10.1016/j.chest.2021.08.074. Epub 2021 Sep 7. No abstract available.

  PMID: 34506792 BACKGROUND

• Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, Diaz-Mendoza J, Greenhill S, Toth J, Feller-Kopman D, Puchalski J, Baram D, Karunakara R, Jimenez CA, Filner JJ, Morice RC, Eapen GA, Michaud GC, Estrada-Y-Martin RM, Rafeq S, Grosu HB, Ray C, Gilbert CR, Yarmus LB, Simoff M; AQuIRE Bronchoscopy Registry. Diagnostic Yield and Complications of Bronchoscopy for Peripheral Lung Lesions. Results of the AQuIRE Registry. Am J Respir Crit Care Med. 2016 Jan 1;193(1):68-77. doi: 10.1164/rccm.201507-1332OC.

  PMID: 26367186 BACKGROUND

• Gildea TR, Folch EE, Khandhar SJ, Pritchett MA, LeMense GP, Linden PA, Arenberg DA, Rickman OB, Mahajan AK, Singh J, Cicenia J, Mehta AC, Lin H, Mattingley JS; NAVIGATE Study Investigators. The Impact of Biopsy Tool Choice and Rapid On-Site Evaluation on Diagnostic Accuracy for Malignant Lesions in the Prospective: Multicenter NAVIGATE Study. J Bronchology Interv Pulmonol. 2021 Jul 1;28(3):174-183. doi: 10.1097/LBR.0000000000000740.

  PMID: 33369988 BACKGROUND

• Folch EE, Labarca G, Ospina-Delgado D, Kheir F, Majid A, Khandhar SJ, Mehta HJ, Jantz MA, Fernandez-Bussy S. Sensitivity and Safety of Electromagnetic Navigation Bronchoscopy for Lung Cancer Diagnosis: Systematic Review and Meta-analysis. Chest. 2020 Oct;158(4):1753-1769. doi: 10.1016/j.chest.2020.05.534. Epub 2020 May 23.

  PMID: 32450240 BACKGROUND

• Mondoni M, Sotgiu G, Bonifazi M, Dore S, Parazzini EM, Carlucci P, Gasparini S, Centanni S. Transbronchial needle aspiration in peripheral pulmonary lesions: a systematic review and meta-analysis. Eur Respir J. 2016 Jul;48(1):196-204. doi: 10.1183/13993003.00051-2016. Epub 2016 May 12.

  PMID: 27174878 BACKGROUND

• Kim YW, Kim HJ, Kwon BS, Lee YJ, Song MJ, Yoon SH, Lim SY, Lee YJ, Park JS, Cho YJ, Lee KH, Chung JH, Han YB, Maldonado F, Ahn SY, Park Y, Joo DH, Lee JH, Lee CT. Diagnostic Yield and Synergistic Impact of Needle Aspiration and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Controlled Trial. Chest. 2025 Jul;168(1):236-247. doi: 10.1016/j.chest.2025.02.015. Epub 2025 Feb 22.

  PMID: 39993594 DERIVED

• Kim YW, Kim HJ, Yoon SH, Lee KH, Park YM, Ahn SY, Song MJ, Kwon BS, Lim SY, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee JH, Lee CT. Evaluation of the synergistic impact of needle and forceps biopsy with electromagnetic navigation bronchoscopy: the CONFIDENT-ENB trial design. BMC Pulm Med. 2022 Aug 19;22(1):319. doi: 10.1186/s12890-022-02104-w.

  PMID: 35986257 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yeon Wook Kim, MD., PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The attending physician and patient will be blinded to the randomized group and which method of biopsy (needle or forceps) would be performed first. The pulmonologist performing the ENB procedure will be informed just before the start of the procedure which group the patient is affiliated to.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Randomized crossover design

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 5, 2021
• Study Start: December 1, 2021
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)