FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097247 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of Contrast Enhanced Ultrasound Guided Biopsy versus Conventional Ultrasound Guided Biopsy in Thoracic Lesions 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahismita Patro  
Designation  Assistant Professor 
Affiliation  AIIMS BHUBANESWAR  
Address  Department of Pulmonary Medicine and Critical Care AIIMS Bhubaneswar Odisha

Khordha
ORISSA
751019
India 
Phone  8763345416  
Fax    
Email  mahismita.patro@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Mahismita Patro  
Designation  Assistant Professor 
Affiliation  AIIMS BHUBANESWAR  
Address  Department of Pulmonary Medicine and Critical Care AIIMS Bhubaneswar Odisha

Khordha
ORISSA
751019
India 
Phone  8763345416  
Fax    
Email  mahismita.patro@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Mahismita Patro  
Designation  Assistant Professor 
Affiliation  AIIMS BHUBANESWAR  
Address  Department of Pulmonary Medicine and Critical Care AIIMS Bhubaneswar Odisha

Khordha
ORISSA
751019
India 
Phone  8763345416  
Fax    
Email  mahismita.patro@gmail.com   
 
Source of Monetary or Material Support  
Intramural fund from All India Institute of Medical Sciences (AIIMS) Bhubaneswar Dist- Khurdha Pin-751019 Odisha India 
 
Primary Sponsor  
Name  Intramural fund from AIIMS Bhubaneswar 
Address  All India Institute of Medical Sciences (AIIMS) Bhubaneswar Dist- Khurdha Pin-751019 Odisha India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahismita Patro   AIIMS Bhubaneswar  Department of Pulmonary and critical care medicine AIIMS Bhubaneswar Odisha Pin- 751019
Khordha
ORISSA 
8763345416

mahismita.patro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 biopsy: The procedure will be done after admission in the pulmonary ward by the PI in association with the Co-PI radiologist. Conventional ultrasound will be first performed on eSoute USG system to evaluate the size, shape, margins, internal echo and vascularity (using colour Doppler mode) of the pulmonary or pleural lesions. Then, contrast-enhanced mode will be enabled in a dual-contrast interface. The ultrasound contrast agent (Sonovue) will be given through an 18 or 20-G intravenous cannula placed in the antecubital vein. A total of 5 ml Sonovue will be constituted, and an aliquot of 1.5 ml Sonovue will be injected, followed by 5 ml of saline chase. As soon as the contrast is injected, the ultrasound will be started in CEUS mode in a continuous manner for 3 minutes. Required images will be saved. After that, the flash mode will be on to destroy the microbubbles, and then a second aliquot of 1.5ml Sonovue solution will be injected, followed by scanning. In this manner, the entire pathology will be imaged, and an appropriate viable area will be identified for biopsy. USG-guided biopsy will be performed immediately after CEUS. Before the biopsy, the puncture site will be anaesthetized using 2 percent lidocaine hydrochloride, and a biopsy will be taken using an 18G semiautomatic or automatic biopsy gun with the aim of obtaining 3–4 more complete tissue strips. The details of the size, depth of the lesion, depth of needle throw, necrosis seen or not, vessels seen or not, and number of tissues taken will be noted. The real-time imaging and procedure video will also be recorded via mobile phone camera and saved for further assessment. Post procedure any complications like pneumothorax, bleeding will be assessed immediately by ultrasound. All will be subjected to a confirmatory chest radiograph to rule out pneumothorax. After an observation time for 2 hours, the patients will be discharged if no complications observed.  
Comparator Agent  conventional USG-guided biopsy  The included patients after randomisation will be included in the control group (conventional USG-guided biopsy group). Procedure details of conventional USG-guided biopsy: The procedure will be done either in the pulmonary OPD or ward based on the patient’s overall clinical need. The pulmonary or pleural lesions targeted for biopsy or pleural thickening will be first assessed by conventional USG on the USG system in the pulmonary OPD or ward. The puncture site will be selected after evaluating the lesion size, shape, margins, internal echo and vascularity using (colour Doppler mode). The puncture site will be anaesthetized using 2percent lidocaine hydrochloride, and a biopsy will be taken using an 18G semiautomatic or automatic biopsy gun with the aim of obtaining at least 3–4 complete tissue strips. The details of the size, depth of the lesion, depth of needle throw, necrosis seen or not, vessels seen or not, and number of tissues taken will be noted. Post procedure any complications like pneumothorax, bleeding will be assessed immediately by USG. All patients will be subjected to a confirmatory chest radiograph to rule out pneumothorax. After an observation time of 2 hours, the OPD patients will be discharged if no complications are observed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the diagnostic yield of CEUS-guided biopsy with conventional USG-guided biopsy in peripheral pulmonary and pleural lesions.  twelve months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the diagnostic yield of CEUS-guided biopsy with conventional USG-guided biopsy in undiagnosed pleural effusions.  twelve months 
2. To assess the factors associated with a negative yield in CEUS-guided biopsy  twelve months 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A biopsy remains imperative in diagnosing many pulmonary and pleural lesions, particularly in non-infectious diseases. Traditionally, percutaneous biopsy of the pulmonary or pleural lesions is performed under computed tomography (CT) guidance. However, CT-guided biopsy is associated with radiation exposure, dependence on the radiologist, transport of the patient to the radiology suite and additional cost. Further, iodinated contrast administration may be required in some patients, thus increasing the risk of contrast-induced nephropathy and limiting its use in seriously ill patients with restricted mobility. Also, CT-guided biopsy is not performed in real-time and is affected by respiration or discomfort causing patient movement. In the recent past, ultrasonography (USG) has evolved as an alternative to CT scan for biopsy of peripheral pulmonary and pleural lesions. USG-guided biopsy can be performed at the bedside, is cheaper and has no radiation exposure. USG has become an indispensable tool in the diagnosis and management of various pleural diseases. Recent studies have shown the diagnostic performance of USG-guided closed pleural biopsy is as good as that of medical thoracoscopy – a procedure which is more invasive and considered gold-standard for the evaluation of undiagnosed pleural effusion. Furthermore, USG-guided biopsy is associated with fewer complications, reduced length of hospital stay and can even be performed on out-patient basis. The drawback of USG is that it has a lower-resolution image compared to a CT scan and requires a learning curve. 

Contrast-enhanced ultrasound (CEUS) is a novel technique that involves the injection of an intravenous contrast agent consisting of sulfur hexafluoride (SonoVue; Bracco S.p.A., Milan, Italy) followed by a guided biopsy. CEUS allows for the more accurate detection of vasculature structures and necrotic areas, thus increasing the biopsy yield. Studies have evaluated the utility of CEUS predominantly in the field of gastroenterology and nephrology, but limited research ihas been done in pulmonary medicine. A 3-year prospective study by Wenwen Sun et al. found that CEUS better delineated the internal necrosis and obvious peripheral vessels compared to conventional ultrasound, and the diagnostic accuracy of CEUS-guided biopsy sampling was 98.91% without any serious adverse events. This is supported by a few other reports on CEUS-guided biopsy in pulmonology. To our knowledge, no such report is available from India. Hence, we are conducting this study to find out the overall clinical utility of CEUS compared to conventional ultrasound-guided biopsy in various pleural and pulmonary diseases, especially in the Indian setting.


 
Close