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A study to determine the Safety and Efficacy of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy.

Safety and Efficacy of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy in the diagnosis of Mediastinal lesions :A Prospective Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/079943
Enrollment
34
Registered
2025-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: R938- Abnormal findings on diagnostic imaging of other specified body structures

Interventions

Intervention1: Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy(EBUS-MCB): All patients with undiagnosed mediastinal lesions will undergo EBUS TBNA and EBUS-MCB in the sample lymph node in the s

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age Greater than 18 years 2.Patients with undiagnosed mediastinal lesions greater than 1 cm requiring pathology examination for diagnosis

Exclusion criteria

Exclusion criteria: 1.Age less than 18 years 2.Highly Vascular,necrotic lymph nodes and unhealthy mucosa at the site of biopsy 3.uncorrectable severe coagulation abnormalities 4.Refractory hypoxemia(sp02 less than 90% with fio2 more than 60) 5.Unstable cardiac arrhythmias,Severe Pulmonary Hypertension(RVSP greater than 50mmHg) 6.Recent MI (less than 4 weeks) or ongoing unstable angina 7.Benign/malignant stenosis of upper airway

Design outcomes

Primary

MeasureTime frame
Safety and efficacy of Endobronchial Ultrasound-Guided Cryobiopsy in the Mediastinal lesions.Safety is determined by complications and efficacy is determined by positive biopsy resultsTimepoint: Safety at time of study(baseline) and till 2 weeks Efficacy at the time of study (baseline)

Secondary

MeasureTime frame
Yield of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy vs Endobronchial Ultrasound-guided Fine needle Aspiration Timepoint: Yield is determined by percentage of patients with positive biopsy results (After the study period)

Countries

India

Contacts

Public ContactNISHANT KUMAR CHAUHAN

Aiims Jodhpur

nishant97@gmail.com8003996884

Outcome results

None listed

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