NCT00888212

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

1 year

First QC Date

April 24, 2009

Last Update Submit

June 19, 2009

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (2)

  • The diagnostic yield of state-of-the art bronchoscopy (including TBB, EBB and TBNA)

    At the end of study

  • The role of endosonography (EUS-FNA or EBUS-TBNA) in demonstrating non-caseating granulomas after a non-qualifying bronchoscopy

    At the end of study

Secondary Outcomes (4)

  • Prevalence of sarcoidosis and alternate diagnosis

    At the end of study

  • Stage distribution

    At the end of study

  • Complication rate of each type of procedure

    At the end of study

  • Cost to obtain a qualifying diagnosis with this strategy in this population

    At the end of study

Study Arms (1)

Bronchoscopy

EXPERIMENTAL

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

Procedure: Bronchoscopy

Interventions

BronchoscopyPROCEDURE

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

Bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with obvious other organ involvement allowing "simple and safe" biopsy
  • Lofgren syndrome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

OLV Ziekenhuis Aalst

Aalst, Belgium

Location

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

ZNA Antwerpen

Antwerp, Belgium

Location

AZ St. Jan Hospitaal Brugge

Bruges, Belgium

Location

Cliniques Universitaires St. Luc

Brussels, Belgium

Location

Höpital Erasme Brussel

Brussels, Belgium

Location

University Hospital Brussels

Brussels, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Virga Jesse Hospitaal

Hasselt, Belgium

Location

UZ Gasthuisberg Leuven

Leuven, Belgium

Location

Heilig Hartziekenhuis Menen

Menen, Belgium

Location

Hôpital Saint Elisabeth Namur

Namur, Belgium

Location

AZ Oudenaarde

Oudenaarde, Belgium

Location

Ampha Ziekenhuis Breda

Breda, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19897553DERIVED

Related Links

MeSH Terms

Conditions

Sarcoidosis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Kurt G. Tournoy, Md, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

BE(14)NL(1)