NCT02459431

Brief Summary

Randomized controlled trial to determine the efficacy of different needles sizes (22G and 21G) used in endobronchial ultrasound guided transbronchial needle aspiration

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

May 26, 2015

Last Update Submit

January 2, 2017

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • The diagnostic yield of EBUS TBNA with 21G and 22G needle in patients with a final diagnosis of sarcoidosis will be assessed for any difference between the two

    outcome assessed 6 months following enrollment of the last patient

Secondary Outcomes (2)

  • Adequacy of samples

    0, 7, 180 days of inclusion

  • Complications

    0, 7 , 180 days of inclusion

Study Arms (2)

21G needle group

ACTIVE COMPARATOR

21 gauge endobronchial ultrasound guided transbronchial aspiration needle ( Vizishot, Olympus ) would be used to perform endobronchial ultrasound guided Transbronchial needle aspiration

Other: 21 G needle group

22G needle group

ACTIVE COMPARATOR

22 gauge endobronchial ultrasound guided transbronchial aspiration needle ( Vizishot, Olympus ) would be used to perform endobronchial ultrasound guided Transbronchial needle aspiration

Other: 22 G needle group

Interventions

21 G needle groupOTHER

Patients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 21 G needle, by random assignment

21G needle group
22 G needle groupOTHER

Patients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 22 G needle, by random assignment

22G needle group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Clinicoradiological suspicion of sarcoidosis where endobronchial ultrasound guided transbronchial needle aspiration is contemplated
  • Enlarged hilar and mediastinal lymph nodes \>10 mm (any axis) on computed tomography of the chest

You may not qualify if:

  • Hypoxemia (SpO2 \<92%) on inspired fraction of oxygen 0.3
  • Treatment with systemic glucocorticoids for more than 2 weeks in the preceding three months
  • Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
  • Failure to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Ritesh Agarwal, DM

    Additional professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional professor

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

IN(1)