Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients With Suspected Sarcoidosis

Summary

Sarcoidosis is a multi-systemic granulomatous disease of unknown cause that is characterized by the formation of non-caseous epithelioid cell granulomas. Sarcoidosis involves the respiratory system in \> 90% of cases, usually the hilar and mediastinal nodes, and, less frequently, the lung tissue. Airway involvement, as judged by clinical features, physiologic testing, imaging techniques, bronchoscopy, and airway mucosal biopsy, has been observed in nearly two-thirds of patients with sarcoidosis. Although sarcoidosis involving thoracic lymph nodes and pulmonary parenchyma is familiar to most clinicians, airway involvement is often overlooked. The frequency of airway involvement increases as the parenchymal disease progresses, and\\airway involvement is associated with increased morbidity, respiratory symptoms, and mortality. The initial airway abnormality is the inflammation manifested by mucosal edema, erythema, and the formation of granulomas. As the airway disease progresses, the mucosa may demonstrate granularity, nodularity, cobble stoning, and friability. Sarcoid granulomas tend to develop along the bronchovascular bundle or in the vicinity of the airways. Overall quality of the endobronchial biopsy (EBB) will depend on the method by which it is obtained and cryo-EBB will most likely to provide better tissue for the diagnosis in comparison to forceps biopsy which has smaller sample as well as crush artifacts. Therefore, it is hypothesized that cryo-EBB will be better than forceps EBB and combined together it will increase the overall diagnostic yield of the sarcoidosis when combined with lymph node sampling by endobronchial ultrasound guided trans-bronchial needle aspiration (EBUS-TBNA).

1. Primary objective: To compare the diagnostic yield of cryo-EBB with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
2. Secondary Objective: To evaluate the overall diagnostic yield of combined endobronchial biopsy and EBUS-TBNA in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.

The relevance and the expected outcome of the proposed study

1. The study will provide insight to obtain an endobronchial biopsy either with cryo probe or forceps
2. The study will also provide information regarding overall increase in diagnostic yield if any when the endobronchial biopsies are combined with EBUS-TBNA.

Conditions

• Sarcoidosis Lung
• Pulmonary Sarcoidosis

Interventions

DEVICE

Cryobiopsy with liquid nitrogen

Forceps vs Cryo Endobronchial Biopsy

DEVICE

Endobronchial Forceps Biopsy

Comparision of forceps and cryo endobronchial biopsy

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences

  lead OTHER_GOV

Principal Investigators

• Ajmal Khan, MBBS, MD, DM · SGPGIMS

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2025-04-15

Completion

2025-04-30

Countries

• India

Study Locations