| CTRI Number |
CTRI/2025/11/097081 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of different flushing methods in liver abscess patients via percutaneous catheter |
|
Scientific Title of Study
|
Comparison Of Continuous Drainage Without Flushing, Normal Saline Flushing, And Metronidazole Flushing Via Percutaneous Catheter In Liver Abscess Patients: Randomized Control 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 Kumar Raviraj Paswan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, RAEBARELI |
| Address |
Ward 6C/6D, 6th Floor
Dept. Of General Surgery
Room No-720, 7th Floor
H1B Hostel
AIIMS, Raebareli
Pincode-229405
District- Raebareli
State- Uttar Pradesh
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8797067564 |
| Fax |
|
| Email |
lafzraviraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Rajput |
| Designation |
Additional Professor and Head, Department of General Surgery |
| Affiliation |
AIIMS, RAEBARELI |
| Address |
Ward 6C/6D, 6th Floor
Dept. Of General Surgery
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9953306717 |
| Fax |
|
| Email |
deepakrajputsjh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Rajput |
| Designation |
Additional Professor and Head, Department of General Surgery |
| Affiliation |
AIIMS, RAEBARELI |
| Address |
Ward 6C/6D, 6th Floor
Dept. Of General Surgery
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9953306717 |
| Fax |
|
| Email |
deepakrajputsjh@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS RAEBARELI,
Dalmau Road, Munshiganj,
District-Raebareli,
Pin code-229405, State-Uttar Pradesh, Country-India
|
|
|
Primary Sponsor
|
| Name |
AIIMS RAEBARELI |
| Address |
Dalmau Road, Munshiganj,
District-Raebareli,
Pin code-229405, State-Uttar Pradesh, Country-India
|
| 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 DEEPAK RAJPUT |
AIIMS RAEBARELI |
Ward 6C And 6D, 6th floor,
Hospital Building,
Department of General Surgery
Rae Bareli
UTTAR PRADESH |
9953306717
deepakrajputsjh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOETHICS CELL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metronidazole flushing via percutaneous catheter measured on USG |
Metronidazole flushing via percutaneous catheter half the volume of liver abscess measured on USG, twice daily.
Total Duration- Twice daily, till the day the liver abscess cavity size has been reduced to 50 % of its initial size as measured on USG on Day 0. |
| Comparator Agent |
No Flushing via percutaneous catheter |
No Flushing via percutaneous catheter. |
| Intervention |
Normal Saline Flushing Via Percutaneous Catheter |
Normal Saline Flushing Via Percutaneous Catheter half the volume of liver abscess measured on USG twice daily.
Total Duration- Twice daily till the day the liver abscess cavity size has been reduced to 50 % of its initial size as measured on USG on Day 0. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults aged 18 years and above with clinically diagnosed liver abscess using clinical signs and/or ultrasonography
2 Percutaneous catheter placed after admission to our institute
3 Single liver abscess
4 No contraindications to metronidazole or catheter insertion.
|
|
| ExclusionCriteria |
| Details |
1 Patients with multiple liver abscesses and multi-loculated abscess
2 Liver abscess associated with biliary tract malignancy
3 Patients with complicated liver abscesses (e.g., ruptured abscess, peritonitis, right pyothorax)
4 Immunocompromised individuals (e.g., HIV, CLD, chemoradiation).
5 Patients who come with catheter in situ
6 Pregnant women.
7 Patients lost to follow-up.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Primary Outcome: Time to 50% reduction in abscess cavity volume, measured by ultrasonography on Days 0, 3, and 7.
|
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of catheter removal; hospital readmission rates within 3 months. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="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
|
LIVER ABSCESS ARE A MAJOR HEALTH CONCERN IN TROPICAL REGION LIKE INDIA, WHERE PYOGENIC AND AMOEBIC FORMS ARE COMMON. ULTRASOUND-GUIDED PCD IS THE STANDARD TREATMENT FOR MODERATE TO LARGE OR REFRACTORY ABCESSES. WHILE CATHETER INSERTION TECHNIQUES ARE ESTABLISHED, POST-INSERTION MANAGEMENT VARIES, WITH NO COMPARATIVE STUDIES ON FLUSHING PROTOCOLS. NORMAL SALINE FLUSHING MAY PREVENT BLOCKAGES AND REMOVE DEBRIS, WHILE METRONIDAZOLE FLUSHING COULD TARGET ANAEROBIC PATHOGENS LOCALLY. THIS VARIABILITY CONTRIBUTES TO INCONSISTENT OUTCOMES AND PROLONGED HOSPITALISATION. THIS STUDY PROSPECTIVELY COMPARES THREE STRATEGIES- PASSIVE DRAINAGE, SALINE FLUSHING, AND METRONIDAZOLE FLUSHING- USING SERIAL ULTRASONOGRAPHY TO ASSESS ABSCESS VOLUME REDUCTION(EQUAL TO OR LESS THAN 50% WITHIN 3 AND 7 DAYS). WE HYPOTHESIZE THAT METRONIDAZOLE FLUSHING MAY ENHANCE OUTCOMES. ADDITIONAL ENDPOINTS INCUDE CATHETER DURATION, RECOVERY TIME, PAIN RELIEFF, FEVER RESOLUTION, LEUKOCYTE NORMALISATION, CATHETER PATENCY, AND HOSPITAL STAY, AIMING TO STANDARDISE POST-PCD PROTOCOLS. |