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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis
• Intervention / Treatment: Device: Cup forceps; Device: Alligator forceps

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Bronchoscopy suite, PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cup forceps; 4 biopsies (transbronchial lung biopsy) with Cup forceps	Device: Cup forceps; In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps
Active Comparator: Alligator forceps; 4 biopsies (transbronchial lung biopsy) with Alligator forceps	Device: Alligator forceps; In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication (Occurrence of bleeding)	Occurrence of bleeding	12 months
Complication (Occurrence of pneumothorax)	Occurrence of pneumothorax	12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Ritesh Agarwal, MD, DM, PGIMER, Chandigarh

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: forceps; transbronchial lung biopsy; flexible bronchoscopy
• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• Other Study ID Numbers: 0810