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EBUS vs EUS-B for Diagnosing Sarcoidosis

Primary Purpose

Sarcoidosis, Endosonography

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Endosonography
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities)
  • Indication for tissue verification of noncaseating granuloma's
  • Provision of a written informed consent

Exclusion Criteria:

  • Life expectancy of less than 6 months
  • Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node)
  • Positive acid-fast bacilli sputum test
  • Contra-indication for endosonography
  • Pregnancy

Sites / Locations

  • Academic Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

EBUS-TBNA using 22G needle

EBUS-TBNA using 25G ProCore needle

EUS-B-FNA using 22G needle

EUS-B-FNA using 25G ProCOre needle

Arm Description

EBUS-TBNA using 22G needle (transbronchial route)

EBUS-TBNA using 25G ProCore needle (transbronchial route)

EUS-B-FNA using 22G needle (transoesophageal route)

EUS-B-FNA using 25G ProCOre needle (transoesophageal route)

Outcomes

Primary Outcome Measures

The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
The sample quality will be assessed by two independent reference pathologists. The performance of each needle (25 ProCore / standard 22 G) will be scored on five items (the modified Mair score).

Secondary Outcome Measures

Full Information

First Posted
August 31, 2015
Last Updated
September 3, 2015
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Cook Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02540694
Brief Title
EBUS vs EUS-B for Diagnosing Sarcoidosis
Official Title
Endobronchial vs. Esophageal Ultrasound for Diagnosing Sarcoidosis: A Randomized Clinical Trial; - A Standard vs. - ProCore Needle Comparison -
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Cook Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rationale: Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion. Secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates. Hypotheses: Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II. 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II. Study design: Investigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals) Study population: Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion. Intervention: EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles. Main study endpoints: The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Endosonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA using 22G needle
Arm Type
Active Comparator
Arm Description
EBUS-TBNA using 22G needle (transbronchial route)
Arm Title
EBUS-TBNA using 25G ProCore needle
Arm Type
Active Comparator
Arm Description
EBUS-TBNA using 25G ProCore needle (transbronchial route)
Arm Title
EUS-B-FNA using 22G needle
Arm Type
Active Comparator
Arm Description
EUS-B-FNA using 22G needle (transoesophageal route)
Arm Title
EUS-B-FNA using 25G ProCOre needle
Arm Type
Active Comparator
Arm Description
EUS-B-FNA using 25G ProCOre needle (transoesophageal route)
Intervention Type
Device
Intervention Name(s)
Endosonography
Other Intervention Name(s)
EBUS, EUS-B
Primary Outcome Measure Information:
Title
The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
Time Frame
2 weeks after the endosonography procedure.
Title
Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.
Description
The sample quality will be assessed by two independent reference pathologists. The performance of each needle (25 ProCore / standard 22 G) will be scored on five items (the modified Mair score).
Time Frame
9 months after inclusion of last patient.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical and radiologic suspicion of sarcoidosis stage I (mediastinal or hilar lymphadenopathy) or stage II (lymphadenopathy and interparenchymal abnormalities) Indication for tissue verification of noncaseating granuloma's Provision of a written informed consent Exclusion Criteria: Life expectancy of less than 6 months Obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node) Positive acid-fast bacilli sputum test Contra-indication for endosonography Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence MM Crombag, MD
Phone
31205664356
Email
l.m.crombag@amc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Jouke T Annema, Prof
Phone
31205664356
Email
j.t.annema@amc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jouke T Annema, Prof
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence MM Crombag, MD
Phone
31205664356
Email
l.m.crombag@amc.nl
First Name & Middle Initial & Last Name & Degree
Jouke T Annema, Prof
Phone
31205664356
Email
j.t.annema@amc.nl

12. IPD Sharing Statement

Citations:
PubMed Identifier
34792268
Citation
Crombag LMM, Mooij-Kalverda K, Szlubowski A, Gnass M, Tournoy KG, Sun J, Oki M, Ninaber MK, Steinfort DP, Jennings BR, Liberman M, Bilaceroglu S, Bonta PI, Korevaar DA, Trisolini R, Annema JT. EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial. Respirology. 2022 Feb;27(2):152-160. doi: 10.1111/resp.14182. Epub 2021 Nov 17.
Results Reference
derived

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EBUS vs EUS-B for Diagnosing Sarcoidosis

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