| CTRI Number |
CTRI/2024/05/067498 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Interventional Radiology] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare treatment of pus collection in liver by draining pus continuously by flexible tube versus aspirating pus using wide bore needle. |
|
Scientific Title of Study
|
A Comparative study of Continuous Catheter Drainage Versus Percutaneous Needle Aspiration for treatment of Liver Abscess : A Superiority 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 |
Dr Shashank A Bhatkar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9834499557 |
| Fax |
|
| Email |
shashankbhatkar27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Siddharth P Dubhashi |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
Room no 207, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9881624422 |
| Fax |
|
| Email |
spdubhashi@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank A Bhatkar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9834499557 |
| Fax |
|
| Email |
shashankbhatkar27@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 |
|
|
Primary Sponsor
|
| Name |
Dr Shashank Bhatkar |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE: 441108 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shashank Bhatkar |
All India Institute of Medical Sciences, Nagpur |
Room no 202, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA |
9834499557
shashankbhatkar27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K750||Abscess of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous catheter drainage by pigtail insertion |
One group will be intervened by drainage of liver abscess by continuous catheter drainage via pigtail insertion,
Output will be measured 24 hourly and imaging will be repeated every 3rd day for residual size of cavity |
| Intervention |
Drainage of liver abscess by percutaneous needle aspiration |
Second group will be intervened by drainage of liver abscess completely by percutaneous needle insertion, and imaging will be repeated every 3rd day for residual size of cavity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
- Pts aged 18-72 yrs
- Pts with liver abscess of cavity size 4 cm or more
- Pts with no prior treatment or history
- Pts with single or multiple abscesses
|
|
| ExclusionCriteria |
| Details |
- Uncorrectable coagulopathy
- Ruptured liver abscess
- Uncertain diagnosis
- Pregnant and less than 18 yrs of age
- Patients not willing for treatment
- Not compliant to follow-up
- Abscess secondary to obstructive jaundice
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of treatment outcomes in terms of clinical, biochemical and radiological parameters for treatment of patients with liver abscess, by continuous catheter drainage via pigtail and percutaneous needle aspiration respectively. |
Improvement in clinical parameters every 24 hours, biochemical and radiological parameters every third day and each parameter 7 days after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay |
Length of hospital stay |
| Complications during hospital stay |
Complications during hospital stay |
| Improvement in biochemical parameters |
At every 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
16/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Proposals should be send to shashankbhatkar27@gmail.com
- For how long will this data be available start date provided 01-05-2024 and end date provided 31-05-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Liver abscess is defined as a collection of suppurative material in liver parenchyma and is one of the cystic lesions of the liver. Abscesses occur when normal hepatic metabolism is overwhelmed or the system fails. Liver abscess is a relatively common clinical problem in India and tropical countries. Liver abscesses , both amoebic and pyogenic , continue to be an important cause of morbidity and mortality in tropical countries. Liver abscess mainly affects the right lobe (~65%) much more commonly than the left lobe (~10–15%) and can also be bilobar (~20–25%). When multiple abscesses are present, pyogenic or mixed infection needs to be suspected. There are three modalities of treatment for liver abscesses - - Antimicrobial therapy : If pyogenic liver abscess is suspected , broad spectrum antibiotics should be started immediately till the culture results come , to control ongoing bacteremia and associated complications. - Interventional therapy for liver abscesses : Traditional treatment modalities have included both continuous catheter drainage and percutaneous needle aspiration, each with its own set of advantages and drawbacks. - Surgical Intervention : Surgical drainage has been reserved for patients who fail to respond to treatment with either aspiration or percutaneous drainage and antibiotics or who have concurrent intra-abdominal pathology which requires surgical management. This study aims to provide a comprehensive comparison of these two surgical interventions, shedding light on their respective impacts on clinical, biochemical, and radiological parameters in patients with liver abscesses.
|