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CTRI Number  CTRI/2018/08/015500 [Registered on: 28/08/2018] Trial Registered Prospectively
Last Modified On: 10/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ULTRASOUND GUIDED ASPIRATION PLUS ANTIBIOTICS VS ANTIBIOTICS IN CHILDREN OF LIVER ABSCESS 
Scientific Title of Study   ULTRASOUND GUIDED ASPIRATION PLUS ANTIBIOTICSVS ANTIBIOTICS IN CHILDREN WITH LIVER ABSCESS: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Narang 
Designation  Professor 
Affiliation  UCMS & GTB Hospital 
Address  Department of Pediatrics UCMS & GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  01122692695  
Fax    
Email  manish_2710@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Narang 
Designation  Professor 
Affiliation  UCMS & GTB Hospital 
Address  Department of Pediatrics UCMS & GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  01122692695  
Fax    
Email  manish_2710@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Manish Narang 
Designation  Professor 
Affiliation  UCMS & GTB Hospital 
Address  Department of Pediatrics UCMS & GTB Hospital Dilshad Garden Delhi

North East
DELHI
110095
India 
Phone  01122692695  
Fax    
Email  manish_2710@yahoo.com  
 
Source of Monetary or Material Support  
Dept of Health Research Ministry of Health and Family Welfare Ministry of Health and Family Welfare, Indian Red Cross Society Building, 1, Red Cross Road, New Delhi-110001. 
 
Primary Sponsor  
Name  Dept of Health Research Ministry of Health and Family Welfare  
Address  Indian Red Cross Society Building 1, Red Cross Road, New Delhi 110001 
Type of Sponsor  Government funding agency 
 
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 Manish Narang  UCMS & GTB Hospital, Delhi  Room No 1104 (1st floor), Pediatrics Emergency (Opposite Burns ward) Department of Pediatrics, Dilshad Garden, Delhi
North East
DELHI 		 01122692695

manish_2710@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instutional Ethical Committee University College of Medical Sciences University of Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K750||Abscess of liver, (2) ICD-10 Condition: K750||Abscess of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antibiotics in pediatric liver abscess   Antibiotics will be used to treat pediatric liver abscess patients 
Intervention  Ultrasound guided percutaneous aspiration plus antibiotics in pediatric liver abscess   Ultrasound guided aspiration and antibiotics will be used to treat pediatric liver abscess patients. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Ultrasound within the preceding seven days suggestive of uncomplicated liver abscess 3-8 cm (for children 1-5 years) or 3-10 cm (for children 5-18 years). 
 
ExclusionCriteria 
Details  1.Left lobe liver abscess
2.Caudate lobe liver abscess
3.Ultrasound features suggestive of imminent rupture i.e., less than 1 cm liver tissue around abscess cavity
4.Associated with other surgical conditions acute appendicitis, acute cholecystitisetc
5.Known immune-compromised state
6.Children with signs and symptoms suggestive of liver cell failure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical cure is defined as:Absence of documented fever, abdominal pain and Ultrasound showing reduction in size of liver abscess.
 		 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare rate of clinical response:
1.Fever resolution time
2. Time to abdominal pain reduction
3.reduction in abdominal tenderness
4.Duration of hospitalization.
5.Treatment failure
6.Adverse outcomes  		 4 weeks 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/08/2018 
Date of Study Completion (India) 30/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is an attempt to compare clinical outcome of two most widely used regimens for management of liver abscess, i.e. percutaneous needle aspiration plus antibiotics and medical management alone. Enrolled patients will be randomized into two groups and treatment will be started. One group will receive antibiotics and aspiration of liver abscess will be carried out within 24-48 hours of admission and after correction of any coagulation abnormalities and initial stabilization of the patient.Another group will receive only antibiotics. Clinical, laboratory and ultrasound parameters will be monitored as per protocol.

 
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