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Completed

NCT Number: NCT00888212

Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OLV Ziekenhuis Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

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

Primary outcomes

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

    Time frame: At the end of study

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

    Time frame: At the end of study

Secondary outcomes

  1. Prevalence of sarcoidosis and alternate diagnosis

    Time frame: At the end of study

  2. Stage distribution

    Time frame: At the end of study

  3. Complication rate of each type of procedure

    Time frame: At the end of study

  4. Cost to obtain a qualifying diagnosis with this strategy in this population

    Time frame: At the end of study

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis (MITOSIS-Trial)

Acronym: MITOSIS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2009
Registry last updated
Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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