Comparison of Transbronchial, Cryoprobe and VATS Biopsy For the Diagnosis of Interstitial Lung Disease (ILD)

NCT01972685 | Completed

• 1 other identifier: Pro00044455
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the sample size, architectural preservation and diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).

Conditions

Interstitial Lung Disease

Keywords

ILD, transbronchial, cryoprobe, VATS

Outcome Measures

Primary Outcomes (1)

• Comparison of biopsy technique

  The number and size of all biopsies, architectural preservation of the airways/alveoli, and pathological diagnosis will be reported by the pathologist. Diagnostic yield will be calculated for each biopsy technique and compared.

  Day of procedure, approximately 3 hours

Study Arms (1)

Cryo vs Transbronchial vs VATS biopsy

OTHER

Each patient will be brought to the operating room and will undergo transbronchial, cryoprobe and VATS biopsy of the lung.

Procedure: Cryobiopsy biopsy; Procedure: Transbronchial Biopsy; Procedure: VATS biopsy

Interventions

Cryobiopsy biopsy PROCEDURE

Cryobiopsy vs. Transbronchial vs. VATS biopsy

Cryo vs Transbronchial vs VATS biopsy

Transbronchial Biopsy PROCEDURE

Cryo vs Transbronchial vs VATS biopsy

VATS biopsy PROCEDURE

Cryo vs Transbronchial vs VATS biopsy

Eligibility Criteria

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

You may qualify if:

• Subject provides informed consent
• Subject is \>18 years of age
• Subject is scheduled to undergo VATS biopsy for suspected ILD as part of their standard medical care
• A negative pregnancy test in women of child-bearing potential
• Subject is mentally capable of understanding study procedures

You may not qualify if:

• Study subject has any disease or condition that interferes with safe completion of the study including:
• Platelet count \< 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) \> 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
• Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) \< 0.8, or radiographically as diffuse bullous disease
• Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
• Hypoxemia with pulse oximetry values \<88% or partial pressure of oxygen in arterial blood (PaO2) \< 60 on baseline oxygen requirements
• Concurrent participation in another study involving investigational drugs or investigational medical devices
• Inability to read and understand the necessary study documents

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (7)

• Griff S, Ammenwerth W, Schonfeld N, Bauer TT, Mairinger T, Blum TG, Kollmeier J, Gruning W. Morphometrical analysis of transbronchial cryobiopsies. Diagn Pathol. 2011 Jun 16;6:53. doi: 10.1186/1746-1596-6-53.

  PMID: 21679402 BACKGROUND

• Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.

  PMID: 19246874 BACKGROUND

• Krasna MJ, White CS, Aisner SC, Templeton PA, McLaughlin JS. The role of thoracoscopy in the diagnosis of interstitial lung disease. Ann Thorac Surg. 1995 Feb;59(2):348-51. doi: 10.1016/0003-4975(94)00844-w.

  PMID: 7847948 BACKGROUND

• Deshmukh SP, Krasna MJ, McLaughlin JS. Video assisted thoracoscopic biopsy for interstitial lung disease. Int Surg. 1996 Oct-Dec;81(4):330-2.

  PMID: 9127787 BACKGROUND

• Krasna MJ, Deshmukh S, McLaughlin JS. Complications of thoracoscopy. Ann Thorac Surg. 1996 Apr;61(4):1066-9. doi: 10.1016/0003-4975(96)00021-5.

  PMID: 8607657 BACKGROUND

• Aktas Z, Gunay E, Hoca NT, Yilmaz A, Demirag F, Gunay S, Sipit T, Kurt EB. Endobronchial cryobiopsy or forceps biopsy for lung cancer diagnosis. Ann Thorac Med. 2010 Oct;5(4):242-6. doi: 10.4103/1817-1737.69117.

  PMID: 20981186 BACKGROUND

• Yarmus L, Akulian J, Gilbert C, Illei P, Shah P, Merlo C, Orens J, Feller-Kopman D. Cryoprobe transbronchial lung biopsy in patients after lung transplantation: a pilot safety study. Chest. 2013 Mar;143(3):621-626. doi: 10.1378/chest.12-2290.

  PMID: 23328889 RESULT

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Momen M Wahidi, MD, MBA

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: October 30, 2013
• Study Start: June 1, 2013
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: July 15, 2019

Record last verified: 2018-11

Locations

US (1)