| CTRI Number |
CTRI/2022/10/046832 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
24/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Single dose steroid on major hepatectomy |
|
Scientific Title of Study
|
Impact of preoperative single dose Methylprednisolone on Major Hepatectomy in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muddada Vivekananda |
| Designation |
M.Ch Resident |
| Affiliation |
Amrita Institute of Medical sciences |
| Address |
M.Ch resident,
Department of Gastrointestinal surgery and Multi Visceral transplantation,
Amrita institute of medical sciences,
Ernakulam,Kerala
Ernakulam
KERALA
682026
India |
| Phone |
9845806688 |
| Fax |
|
| Email |
vivekananda70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrO V Sudheer |
| Designation |
Head of the Department |
| Affiliation |
Amrita Institute of Medical sciences |
| Address |
Head of the Department,
Department of Gastrointestinal surgery and Multi Visceral transplantation,
Amrita institute of medical sciences,
Ernakulam,Kerala
Ernakulam
KERALA
682026
India |
| Phone |
9447129111 |
| Fax |
|
| Email |
ovsudheer@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Muddada Vivekananda |
| Designation |
M.Ch Resident |
| Affiliation |
Amrita Institute of Medical sciences |
| Address |
M.Ch resident,
Department of Gastrointestinal surgery and Multi Visceral transplantation,
Amrita institute of medical sciences,
Ernakulam,Kerala
Ernakulam
KERALA
682026
India |
| Phone |
9845806688 |
| Fax |
|
| Email |
vivekananda70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
Muddada Vivekananda |
| Address |
M.Ch Resident,
Department of Gastrointestinal surgery and Multivisceral Transplantation,
Amrita institute of medical sciences,
Ernakulam,Kerala |
| 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 |
| Muddada Vivekananda |
Amrita Institute of medical sciences |
Department of Gastrointestinal surgery and multi visceral transplantation, New OPD block,Second floor
Ernakulam
KERALA |
9845806688
vivekananda70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita institute of medical sciences, institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methylprednisolone |
in the study group 500mg Intravenous Methylprednisolone will be given single dose
Drug will be given one time (1) at the time of induction of anaesthesia |
| Comparator Agent |
Steroid will not be given |
In control/Comparator group no drug will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Major Hepatectomy |
|
| ExclusionCriteria |
| Details |
1.Patients who deny consenting for study
2.Patients who are on steroids for other conditions
3.Patients undergoing recipient Hepatectomy
4.Patients undergoing Minor hepatectomy/Non anatomic liver resections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative complications |
Within 90days after Liver resection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.peri-operative Mortality
2.Inflammatory marker - CRP at baseline and on POD 1,3 and 5 and during follow up visit
3.Levels of Total Bilirubin,Direct bilirubin,AST,ALT,PT/INR at baseline and on POD 1,3,5 and during follow up visit
4.Length of Hospital stay |
With in 90days after liver resection |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - once the study is published
- For how long will this data be available start date provided 01-06-2024 and end date provided 01-07-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is a randomised controlled trail evaluating the imapct of single dose Methylprednisolone on major hepatectomy in adults in 120 patients that will be conducted in single centre in India.The primary outcome is to compare post operative complications within 90 days after liver resection.The secondary outcome will be to compare Perioperative mortality,Levels of CRP,LFT and Length of Hospital stay. |