| CTRI Number |
CTRI/2022/06/043339 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation Of BISAP Score and CT Findings For Assessing The Severity Of Acute Pancreatitis |
|
Scientific Title of Study
|
A Study Of Evaluation Of Prognostic Usefulness Of BISAP And CT Severity Index In Predicting The Severity Of Acute Pancreatitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gavara Bhavana |
| Designation |
Dnb Resident (General Surgery ) |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital ,Shalimar Bagh ,New Delhi
110088
North West
DELHI
110088
India |
| Phone |
9154464333 |
| Fax |
|
| Email |
rimsbhavana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwas Sharma |
| Designation |
Senior Consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital ,Shalimar Bagh ,New Delhi , 110088
North West
DELHI
110088
India |
| Phone |
9810293767 |
| Fax |
|
| Email |
vishwaskirti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gavara Bhavana |
| Designation |
Dnb Resident (General Surgery ) |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital ,Shalimar Bagh ,New Delhi , 110088
North West
DELHI
110088
India |
| Phone |
9154464333 |
| Fax |
|
| Email |
rimsbhavana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max super speciality hospital , shalimar bagh |
|
|
Primary Sponsor
|
| Name |
General Surgery Department |
| Address |
Max Super Speciality Hospital ,Shalimar Bagh ,New Delhi , 110088 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bhavana Gavara |
Max Super Speciality Hospital , Shalimar Bagh |
General Surgery Department ,Ground Floor ,Shalimar Bagh .
North West
DELHI |
9154464333
rimsbhavana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Health Care Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with primary diagnosis of acute pancreatitis
2)patients with suiscipicion of pancreatitis
3)all age groups and both sexes - male and female |
|
| ExclusionCriteria |
| Details |
1) proven cases of chronic pancreatitis
2) incomplete data
3)Death withn 48 hrs of admission
4)Hereditery pancreatitis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To evaluate the prognostic usefulness of BISAP and CT SEVERITY INDEX in predicting the severity of disease
-To identify the patients at risk of progression and risk of developing organ failure
|
within 4 weeks - 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the outcome of study with the scores observed , in terms of disease severity |
12 months |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This trail is observation study in patients of pancreatitis in evaluation of prognostic usefulness of scoring systems BISAP and CTSI in predicting the severity of disease and identify the patients those are at high risk of progression and are at the risk of development of organ failure |