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Comparative study of Contrast Enhanced Ultrasound Guided Biopsy versus Conventional Ultrasound Guided Biopsy in Thoracic Lesions

Comparative Assessment of the Diagnostic Yield of Contrast Enhanced Ultrasound Guided Biopsy versus Conventional Ultrasound Guided Biopsy in Thoracic Lesions: An Open Label Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097247
Enrollment
130
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: J988- Other specified respiratory disorders

Interventions

Intervention1: contrast enhanced ultrsaound guided biopsy of thoracic lesions: The included patients after randomisation will be included in the intervention group. Procedure details of CEUS-guided

Sponsors

Intramural fund from AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults with equal to or more than 18 years of age presenting to the Pulmonary OPD or IPD with peripheral pulmonary lesions, pleural lesions (pleural thickening or pleural nodularity) and undiagnosed pleural effusion having a clinical indication for trans-thoracic biopsy. 2. The lesions should have been confirmed on the chest computed tomography and detectable by chest ultrasound. 3. The minimum size of lesions should be at least 10 mm or more on ultrasound imaging. For undiagnosed pleural effusion, the pleural thickening should be at least 10 mm or more, which is considered suitable for obtaining a biopsy

Exclusion criteria

Exclusion criteria: 1. Any contraindications to biopsy (low platelet count, coagulation defects or bleeding diathesis, clinical instability or unsafe location of biopsy) 2. Patients refusing consent 3. Any contraindication to ultrasound contrast agents such as a prior history of an allergic reaction, pregnancy, severe pulmonary hypertension or presence of right-to-left cardiac shunts

Design outcomes

Primary

MeasureTime frame
To compare the diagnostic yield of CEUS-guided biopsy with conventional USG-guided biopsy in peripheral pulmonary and pleural lesions.Timepoint: twelve months

Secondary

MeasureTime frame
1. To compare the diagnostic yield of CEUS-guided biopsy with conventional USG-guided biopsy in undiagnosed pleural effusions.Timepoint: twelve months;2. To assess the factors associated with a negative yield in CEUS-guided biopsyTimepoint: twelve months

Countries

India

Contacts

Public ContactMahismita Patro

AIIMS BHUBANESWAR

mahismita.patro@gmail.com8763345416

Outcome results

None listed

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