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CTRI Number  CTRI/2024/05/066784 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Radiation dose reduction in biliary intervention procedures using radiation protection drape 
Scientific Title of Study   Efficacy of the RADPAD Protection Drape in Reducing Operators’ Radiation Exposure in biliary interventions :A Randomized controlled Trial 
Trial Acronym  DRIP: Dose reduction in PTBD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tara Prasad Tripathy 
Designation  Assistant Professor 
Affiliation  AIIMS bhubaneswar 
Address  room number 8, corridor number 4, Department of radiodiagnosis, Division of interventional radiology

Khordha
ORISSA
751019
India 
Phone  8575827990  
Fax    
Email  taraprasad.mkcg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tara Prasad Tripathy 
Designation  Assistant Professor 
Affiliation  AIIMS bhubaneswar 
Address  Room number 8, corridoe number 4, Division of interventional radiology,Department of radiodiagnosis


ORISSA
751019
India 
Phone  8575827990  
Fax    
Email  taraprasad.mkcg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tara Prasad Tripathy 
Designation  Assistant Professor 
Affiliation  AIIMS bhubaneswar 
Address  Room number 8, Corridor of number 4, Division of interventional radiology, Department of radiodiagnosis


ORISSA
751019
India 
Phone  8575827990  
Fax    
Email  taraprasad.mkcg@gmail.com  
 
Source of Monetary or Material Support  
AIIMS bhubaneswar, Sijua Patrapada, odisha 751019 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Government medical college 
 
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 Taraprasad Tripathy  AIIMS BBSR DEPT OF RADIODIAGNOSIS  Room number 8, corridor number 4, Divison of interventional radiology, AIIMS BBSR SIJUA PATRAPADA 751019
Khordha
ORISSA 		 8575827990

taraprasad.mkcg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute 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: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE(PTBD) with radiation protection drape  PTBD to be done with radiation protection drape and reduction in radiation dose to operator will be measured. 
Comparator Agent  PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE(PTBD) without radiation protection drape  PTBD to be done without radiation protection drape and radiation dose to operator will be measured. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Moderate and gross dilated IHBRD
2.Cholangitis/hyperbilirubinemia for biliary drainage
3.Left sided PTBD
 
 
ExclusionCriteria 
Details  1.Ascites
2.Deranged coagulation profile
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Dose reduction in operator during biliary interventions.  during procedure 
 
Secondary Outcome  
Outcome  TimePoints 
dose reduction in patients  during procedure 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   14/05/2024 
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="0"
Months="6"
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  

Even though technology has advanced, exposure to low-dose radiation is an indispensable aspect for an interventional radiologist. The radiation dose that the operator receives varies greatly from procedure to procedure and is influenced by the level of experience, the radiation equipment, the type of surgery, and the patient’s characteristics. An increase in the number and intricacies of procedures causes a further rise in the operator’s being subjected to scatter radiation in the catheterization lab. 

Exposure to radiation can cause deterministic and stochastic effects. A case series of interventional cardiologists with left-sided brain tumours raises the pertinent issue newer and better safety precautions to safeguard operators. 

The RADPAD (RADPAD 5100A-O; Worldwide Innovations & Technologies, Inc, Lenexa, KS) is a sterile, disposable, lead-free shield that acts as a barrier between the image intensifier and the operator to reduce operator received scatter radiation . No previous studies are available on biliary interventions. The primary aim of the study is to examine the effect of a RADPAD on the operator’s radiation dose, during biliary interventions in a randomized controlled trial.

 
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