Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis

NCT ID: NCT00888212

Last Updated: 2009-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.

Detailed Description

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Conditions

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Sarcoidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Bronchoscopy

Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type PROCEDURE

Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy

Interventions

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Bronchoscopy

Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 y
* Suspicion of thoracic sarcoidosis and need for tissue confirmation
* Recent (\<6 weeks) RX and CT-thorax (HRCT not compulsory)
* Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
* Written informed consent

Exclusion Criteria

* Patients with obvious other organ involvement allowing "simple and safe" biopsy
* Lofgren syndrome
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Kurt G. Tournoy, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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OLV Ziekenhuis Aalst

Aalst, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Site Status

ZNA Antwerpen

Antwerp, , Belgium

Site Status

AZ St. Jan Hospitaal Brugge

Bruges, , Belgium

Site Status

Cliniques Universitaires St. Luc

Brussels, , Belgium

Site Status

Höpital Erasme Brussel

Brussels, , Belgium

Site Status

University Hospital Brussels

Brussels, , Belgium

Site Status

CHU Charleroi

Charleroi, , Belgium

Site Status

University Hospital Ghent

Ghent, , Belgium

Site Status

Virga Jesse Hospitaal

Hasselt, , Belgium

Site Status

UZ Gasthuisberg Leuven

Leuven, , Belgium

Site Status

Heilig Hartziekenhuis Menen

Menen, , Belgium

Site Status

Hôpital Saint Elisabeth Namur

Namur, , Belgium

Site Status

AZ Oudenaarde

Oudenaarde, , Belgium

Site Status

Ampha Ziekenhuis Breda

Breda, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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Tournoy KG, Bolly A, Aerts JG, Pierard P, De Pauw R, Leduc D, Leloup A, Pieters T, Slabbynck H, Janssens A, Carron K, Schrevens L, Pat K, De Keukeleire T, Dooms C. The value of endoscopic ultrasound after bronchoscopy to diagnose thoracic sarcoidosis. Eur Respir J. 2010 Jun;35(6):1329-35. doi: 10.1183/09031936.00111509. Epub 2009 Nov 6.

Reference Type DERIVED
PMID: 19897553 (View on PubMed)

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2008/069

Identifier Type: -

Identifier Source: org_study_id

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