| 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
|
|
|
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
|
|
|
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. |