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

NCT06853834 | Recruiting DMC

• 1 other identifier: DMEBBRCT001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Primary objective: To compare the diagnostic yield of cryo-EBB with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
2. 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.
3. 3.The study will provide insight to obtain an endobronchial biopsy either with cryo probe or forceps
4. 4.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

Keywords

Forceps Endobronchial Biopsy; Cryo-Endobronchial Biopsy; Pulmonary Sarcoidosis; Diagnostic yield of endobronchial biopsy in sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  To compare the diagnostic yield of cryo-endobronchial biopsy with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.

  Two week after the end of enrollment

Secondary Outcomes (3)

• Over all diagnostic yield

  Two week after the end of enrollment

• Complications

  From enrollment to Two week after the end of enrollment

• Dignostic yield based on endobronchial abnormality

  Two week after the end of enrollment

Study Arms (2)

Cryo-Endobronchial Biopsy

EXPERIMENTAL

Endobronchial biopsy obtained using CRYO-Probe

Device: Cryobiopsy with liquid nitrogen

Forceps Endobronchial Biopsy

ACTIVE COMPARATOR

Endobronchial Biopsy using Standard Bronchoscopic Biopsy Forceps

Device: Endobronchial Forceps Biopsy

Interventions

Cryobiopsy with liquid nitrogen DEVICE

Forceps vs Cryo Endobronchial Biopsy

Also known as: Forceps biopsy, Cryo Biopsy

Cryo-Endobronchial Biopsy

Endobronchial Forceps Biopsy DEVICE

Comparision of forceps and cryo endobronchial biopsy

Also known as: Cryo Biopsy, Forcpes Biopsy

Forceps Endobronchial Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients of suspected pulmonary sarcoidosis scheduled for routine EBUS-TBNA

You may not qualify if:

• Patient age less than 18 years
• Patients with co-morbid conditions like Diabetes mellitus, renal failure, chronic liver disease or any other chronic disease.
• Patients already on treatment with steroids or h/o steroids intake in last three months or on disease modifying and immunosuppressive drugs.
• Final Diagnosis other than sarcoidosis

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Ajmal Khan, MBBS, MD, DM

  SGPGIMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajmal Khan, MBBS, MD, DM

CONTACT

+919878678689; drajmal13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Pathologist examining the sample will be blinded for the type of forceps vs cryo biopsy
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 3, 2025
• Study Start: January 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

IN (1)