NCT02405897

Brief Summary

Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves multiple body organs. The diagnosis requires the presence of compatible clinicoradiological features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that can be sampled by, performing various bronchoscopic techniques. In a recent study the use of alligator forceps had a better yield in comparison to cup forceps. The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

March 23, 2015

Last Update Submit

January 2, 2017

Conditions

Sarcoidosis

Keywords

flexible bronchoscopytransbronchial lung biopsyforceps

Outcome Measures

Primary Outcomes (3)

  • Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)

    Size of tissue: Size of the tissue will be visually assessed as small if it does not fill the cup, medium if it fills the cup and large if comes out of the cup

    12 months

  • Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)

    Size of tissue in millimeters during histopathology

    12 months

  • Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)

    Histopathology examination and findings

    12 months

Secondary Outcomes (2)

  • Complication (Occurrence of bleeding)

    12 months

  • Complication (Occurrence of pneumothorax)

    12 months

Study Arms (2)

Cup forceps

EXPERIMENTAL

4 biopsies (transbronchial lung biopsy) with Cup forceps

Device: Cup forceps

Alligator forceps

ACTIVE COMPARATOR

4 biopsies (transbronchial lung biopsy) with Alligator forceps

Device: Alligator forceps

Interventions

Cup forcepsDEVICE

In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps

Cup forceps
Alligator forcepsDEVICE

In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps

Alligator forceps

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a clinical diagnosis of sarcoidosis undergoing flexible bronchoscopy
  • age group of 12 to 90 years;
  • hemodynamically stable (systolic BP \> 100 mm Hg without the need of vasopressors); and
  • ability to provide informed consent to participate in the study.

You may not qualify if:

  • hemoglobin less than 8 gm/dL;
  • platelet count of less than 80000;
  • bleeding diathesis;
  • prothrombin time or activated partial thrombin time prolongation of more than 6 seconds when compared to control;
  • baseline room air saturation less than 90%;
  • pregnancy; and,
  • failure to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Ritesh Agarwal, MD, DM

    PGIMER, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

IN(1)