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Smaller vs. Larger Probes for Lung Biopsies in Interstitial Lung Disease: A Study on the Safety and Effectiveness comparison between the two intervention modalities.

To Study the Efficacy and Safety of Trans Bronchial Lung Cryo-Biopsy using 1.1 mm Vs 1.7 mm Cryoprobe in patients with Diffuse Parenchymal Lung Disease - A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092221
Enrollment
60
Registered
2025-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J849- Interstitial pulmonary disease, unspecified

Interventions

Intervention1: TBLC (1.1mm): Trans Bronchial Lung Cryo-Biopsy using 1.1 mm Cryoprobe Control Intervention1: TBLC(1.7 mm): Trans Bronchial Lung Cryo-Biopsy using 1.7 mm Cryoprobe

Sponsors

National Institute of TB and Respiratory Diseases
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age more than 18 years. 2.Patients with forced vital capacity more than 50 percentage and diffusing capacity of lungs for carbon monoxide more than 35 percentage. 3.Patients willing to provide informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with Coagulopathy (thrombocytopenia less than 50000, prothrombin time international normalized ratio more than 1.5) 2.Patients with hemodynamic instability. 3.Patients with severe pulmonary hypertension (with estimated right ventricular systolic pressure more than 40 mm Hg or signs of right ventricular dysfunction on echocardiogram) 4.Patients with severe hypoxemia (PaO2 less than 55 mm Hg) on room air. 5.Patients with Diffuse Bullous Disease. 6.Patients unwilling to provide consent.

Design outcomes

Primary

MeasureTime frame
1.To compare the Diagnostic yield of Trans Bronchial Lung Cryo-Biopsy using 1.1 mm Vs 1.7 mm Cryoprobe in patients with Diffuse Parenchymal Lung Disease. 2.To compare the Safety of Trans Bronchial Lung Cryo-Biopsy using 1.1 mm Vs 1.7 mm Cryoprobe in patients with Diffuse Parenchymal Lung Disease. Timepoint: at baseline and 2 weeks

Secondary

MeasureTime frame
1. To Study the Clinico Radiological & Histopathological profile of these patients. 2. To monitor the procedural time & the patient s willingness to return for repeat procedure, if required. Timepoint: at baseline & 2 weeks

Countries

India

Contacts

Public ContactDr Jitendra Kumar Saini

National Institute of TB and Respiratory Diseases

drrizwanpulmo@gmail.com9489465172

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026