Predictive Diagnostic Criteria for Diagnosis of Transbronchial Biopsies, Echo-guided by Mini-probe in Peripheral Lung Lesions (EBUS-R-PTB)

The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are not accessible to the transparietal aspirate under scanner. The overall sensitivity of flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%. On the other hand, the complication rate of this technique is not negligible, with in the study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the only risk factor actually found is the existence of emphysema. However, thoracic drainage is rarely necessary.

Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hürter and Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is 73% for the histological diagnosis. From the same author, a randomized trial compared the diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to the success or failure of the first procedure requiring further investigations . Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a histological diagnosis of these peripheral lung lesions

Study Overview

• Status: Completed
• Conditions: Transbronchial Biopsies; Peripheral Lung Lesion
• Intervention / Treatment: Other: Define predictive criteria for the diagnostic performance of echo-guide samples by mini-probe in peripheral lung lesions

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a mini-probe fibroscopy

Description

Inclusion Criteria:

• All patients who underwent mini-probe fibroscopy at Amiens University Hospital from January 2013 to March 2016

Exclusion Criteria:

• No

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analyze predictive criteria of the performance diagnosis by echo-guide sampling by mini-probe	39 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RNI2016-40 Dr Basille

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No