| CTRI Number |
CTRI/2023/01/048763 [Registered on: 05/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing efficacy of Ultrasonography Guidance versus Computed Tomography Guidance for Peripheral Lung Lesion Biopsies |
|
Scientific Title of Study
|
A Comparative Analysis of performance parameters of Ultrasonography Guidance versus Computed Tomography Guidance for Peripheral Lung Lesion Biopsies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurabh Karmakar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Room no. 330, 3rd Floor, OPD Building, Pulmonary Medicine Department
AIIMS, Patna
Patna
BIHAR
801507
India |
| Phone |
9839443375 |
| Fax |
0121 |
| Email |
drsaurabhkarmakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Karmakar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Room no. 330, 3rd Floor, OPD Building, Pulmonary Medicine Department
AIIMS, Patna
Patna
BIHAR
801507
India |
| Phone |
9839443375 |
| Fax |
0121 |
| Email |
drsaurabhkarmakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh kumar Yadav |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
3rd Floor, OPD Building, Pulmonary Medicine Department
AIIMS, Patna
Patna
BIHAR
801507
India |
| Phone |
7014291427 |
| Fax |
|
| Email |
raj.nitrd13@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
OPD Building, 3rd Floor, Department of pulmonary medicine
AIIMS, Patna |
| Type of Sponsor |
Government medical college |
|
|
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 Saurabh Karmakar |
All India Institute of Medical Sciences, Patna |
OPD Building, 3rd floor, Department of Pulmonary medicine
Patna
BIHAR |
9839443375
drsaurabhkarmakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CT guided lung biopsy (Gold standard method) |
Computed tomography guided trans-thoracic biopsy of peripheral lung lesion will be done with the help of c0-axial biopsy needle. |
| Intervention |
USG Guided biopsy lung biopsy |
Real time based USG Guided trans-thoracic biopsy of peripheral lung lesion will be done with help of co-axial biopsy needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Intrathoracic peripheral lung lesions of size more than 1cm and abutting the pleura.
2. Peripheral lung lesion not lying in close proximity of major organ or blood vessels based of
CT /MRI Chest.
3. Lung lesion visible on Ultrasongraphy.
4. Age > 18 years of age.
5. Patients giving informed consent |
|
| ExclusionCriteria |
| Details |
1. Central lung lesions not abutting pleura or ground-glass lesions.
2. Lesion lying in close proximity to major blood vessel or major organ.
3. Lesion not visible on Ultrasonography (Emphysematous overlying lung, located behind rib or scapula)
4. Age < 18 years of age.
5. Patients not giving informed consent.
6. Patients with Thrombocytopenia.
7. Patients with deranged coagulation profile. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of US guided biopsy of peripheral lung lesion with CT guided biopsy. |
Outcome will be assessed at end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the safety or complications of Ultrasonography guided biopsy of peripheral lung
lesion to CT guided.
2. To assess suitability in debilitated and uncooperative patients. |
Outcome will be assessed at end of study and efficacy of both procedures would be compared |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/01/2023 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Computed tomography and radiology are two most important diagnostic modality for chest imaging however ultrasonography being a safe procedure has underutilized application in chest. Ultrasonography can be effective for guiding percutaneous thoracic interventions including lung, pleural and mediastinal biopsies. It allows real time based visualisation of needle during procedure and has added benefits of low cost, availability and potential time saving procedure. Purpose of this study is to evaluate the selection, safety and efficacy of US guidance biopsies of peripheral lung biopsies with CT guidance. |