| CTRI Number |
CTRI/2024/04/065941 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| 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
|
Treatment of liver abscess by emergency doctors versus radiologists |
|
Scientific Title of Study
|
Bedside Percutaneous Drainage of Liver Abscess in the Emergency Department by Trained Emergency Physicians versus Radiologist A Non Inferiority Randomized 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 |
NAYER JAMSHED |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
CONSULTANT ROOM (EM-3), DEPT OF EMERGENCY MEDICINE, AIIMS NEW DLEHI
South West
DELHI
110029
India |
| Phone |
9040685958 |
| Fax |
|
| Email |
jamshednayer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NAYER JAMSHED |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
CONSULTANT ROOM (EM-3), DEPT OF EMERGENCY MEDICINE, AIIMS NEW DLEHI
South West
DELHI
110029
India |
| Phone |
9040685958 |
| Fax |
|
| Email |
jamshednayer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NAYER JAMSHED |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
CONSULTANT ROOM (EM-3), DEPT OF EMERGENCY MEDICINE, AIIMS NEW DLEHI
South West
DELHI
110029
India |
| Phone |
9040685958 |
| Fax |
|
| Email |
jamshednayer@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| INDIAN COUNCIL OF MEDICAL RESEARCH, V. Ramalingaswami Bhawan, P.O. Box No. 4911. Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DEPT OF EMERGENCY MEDICINE, AIIMS New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 NAYER JAMSHED |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
EM-1, DEPARTMENT OF EMERGENCY MEDICINE, AIIMS New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI |
9040685958
jamshednayer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS NEW DELHI |
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 |
Emergency physician driven liver abscess drainage |
A trained emergency physician performing the percutaneous liver abscess drainage procedure bedside, using point-of-care ultrasound. It will be done in the emergency department. It is a one-time procedure and pigtail catheter will be in place as per the clinical indications. |
| Comparator Agent |
Radiologist driven liver abscess drainage |
Radiologist performing the liver abscess drainage procedure in the interventional radiology suite. It is a one-time procedure and pigtail catheter will be in place as per the clinical indications.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with a diagnosis of liver abscess in the emergency department with an indication of urgent percutaneous drainage |
|
| ExclusionCriteria |
| Details |
Organised liver abscess or no urgent indication of emergency percutaneous drainage or thrombocytopenia or coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ED length of stay (in hours) |
TILL DISCHARGED FROM EMERGENCY DEPARTMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of peri-procedure complications: abscess rupture, development of intraabdominal compartment syndrome or peritonitis, evidence of intraabdominal bleeding, continuous bleeding from the puncture site, hemodynamic instability, intractable coughs or hiccups, shortness of breath, upper gastrointestinal bleeding, lower gastrointestinal bleeding, pericardial effusion, and death |
Within 6 hours of the procedure |
| Incidence of complications within the next week |
Within the next 7 days of the procedure |
| Time duration from the time of diagnosis of the liver abscess to percutaneous drainage time |
Time of Diagnosis to Procedure |
| Total duration of catheter requirement for adequate treatment of liver abscess |
From insertion of catheter to removal of catheter |
| Patients satisfaction |
during the emergency department stay |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/05/2024 |
| 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="2"
Months="0"
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
|
Rationale: Early diagnosis of liver abscess and immediate intervention with ultrasound-guided percutaneous drainage not only lead to better patient prognosis but can also lead to a significant decrease in the ED waiting time. Trained emergency physicians (EP) can perform the procedure immediately in the ED Novelty: To the best of our knowledge, this will be the first study comparing the feasibility, efficacy, and safety of EP as the immediate performer of liver abscess drainage. Objectives: The primary objective of this study is to investigate the role of emergency physicians as a performer of liver abscess drainage compared to a radiologist in terms of ED length of stay. The secondary objectives will be to assess differences in complications, clinical outcomes, and patient satisfaction. Methods: This randomized controlled trial (RCT) will be conducted in the ED of AIIMS New Delhi. The arms will be according to the performer, i.e., an emergency physician (EP-driven) versus a radiologist (Radiology-driven). A total of fifty-seven patients will be included in each arm. All adult patients with a diagnosis of liver abscess in the ED will be included, irrespective of clinical severity. Patients with organized liver abscess contents, abscess size < 5cm coagulopathy, thrombocytopenia, or any other contraindications. Expected outcomes: We hypothesize that the ‘EP-driven’ procedure will result in a significantly shorter length of ED stay and better patient satisfaction. The complication rates and duration of the in-situ catheter requirement are expected to be similar in both arms. |