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A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cup forceps
Alligator forceps
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis focused on measuring flexible bronchoscopy, transbronchial lung biopsy, forceps

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Bronchoscopy suite, PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cup forceps

Alligator forceps

Arm Description

4 biopsies (transbronchial lung biopsy) with Cup forceps

4 biopsies (transbronchial lung biopsy) with Alligator forceps

Outcomes

Primary Outcome Measures

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
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Size of tissue in millimeters during histopathology
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)
Histopathology examination and findings

Secondary Outcome Measures

Complication (Occurrence of bleeding)
Occurrence of bleeding
Complication (Occurrence of pneumothorax)
Occurrence of pneumothorax

Full Information

First Posted
March 23, 2015
Last Updated
January 2, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02405897
Brief Title
A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis
Official Title
A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sarcoidosis is a multisystem disorder characterized by granulomatous inflammation involving various body organs. The diagnosis is based on presence of fulfillment of compatible clinicoradiological features and histologic evidence of non-caseating granuloma after exclusion of other known causes for granulomatous inflammation.1 As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, performing various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling. The diagnostic yield of TBLB in sarcoidosis in stage I and II varies from 31%2 to 69.6%.3 Transbronchial lung biopsy (TBLB) is performed with flexible bronchoscopy under the effect of local anesthesia and is the most commonly used bronchoscopic procedure to diagnose a wide array of lung diseases. It is performed as an outpatient procedure and is associated with minimal complications such as bleeding, pneumothorax and others.4 The procedure can be performed either as a blindly or under fluoroscopic guidance. The yield of TBLB varies depending upon the extent of disease, size of tissue, number of alveoli, number of biopsies, whether the sample floats or not and the size of forceps.5-12 The diagnostic yield of TBLB in sarcoidosis depends on the radiological stage and varies from 50-65% in stage I to 80 to 85% in stage II.13-15 The diagnostic yield also depends on the number of biopsy specimens (ten in stage I and 4-6 in stage II and III).9,10 In a recent study comprising of 44 patients with 176 samples, the use of alligator forceps yielded larger samples with lesser incidence of complications (major bleeding, alligator v/s cup forceps respectively, 1% v/s 5.7% and pneumothorax, 4.5 %v/s 9.1%). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
flexible bronchoscopy, transbronchial lung biopsy, forceps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cup forceps
Arm Type
Experimental
Arm Description
4 biopsies (transbronchial lung biopsy) with Cup forceps
Arm Title
Alligator forceps
Arm Type
Active Comparator
Arm Description
4 biopsies (transbronchial lung biopsy) with Alligator forceps
Intervention Type
Device
Intervention Name(s)
Cup forceps
Intervention Description
In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps
Intervention Type
Device
Intervention Name(s)
Alligator forceps
Intervention Description
In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps
Primary Outcome Measure Information:
Title
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Description
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
Time Frame
12 months
Title
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)
Description
Size of tissue in millimeters during histopathology
Time Frame
12 months
Title
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)
Description
Histopathology examination and findings
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complication (Occurrence of bleeding)
Description
Occurrence of bleeding
Time Frame
12 months
Title
Complication (Occurrence of pneumothorax)
Description
Occurrence of pneumothorax
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD, DM
Organizational Affiliation
PGIMER, Chandigarh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronchoscopy suite, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

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A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis

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