| CTRI Number |
CTRI/2024/06/068370 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study For Severity Assessment Of Acute Pancreatitis Comparing BISAP And APACHE-II Scoring |
|
Scientific Title of Study
|
BISAP vs APACHE-II Scoring System for Severity Assessment of
Acute Pancreatitis: A Comparative Observational Study at AIIMS Raipur |
| 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 Parth Patel |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Department of General Surgery, AIIMS Raipur |
| Address |
Department of General Surgery
417, 4th Floor, D Block, AIIMS Raipur, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7016419004 |
| Fax |
|
| Email |
parthsatani7019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tridip Dutta Baruah |
| Designation |
Additional Professor |
| Affiliation |
Department of General Surgery, AIIMS Raipur |
| Address |
Department of General Surgery
417, 4th floor, D block, AIIMS RAIPUR, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7016419004 |
| Fax |
|
| Email |
tridipduttabaruah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Patel |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Department of General Surgery, AIIMS Raipur |
| Address |
Department of General Surgery
417, 4th floor, D Block,AIIMS Raipur, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7016419004 |
| Fax |
|
| Email |
parthsatani7019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, AIIMS Raipur
Department of General Medicine,AIIMS Raipur |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [] |
|
|
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 Parth Patel |
All India Institute of Medical Sciences, Raipur |
Department of General Surgery and Department of General Medicine
Raipur
CHHATTISGARH |
7016419004
parthsatani7019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL
|
NIL |
| Comparator Agent |
NIL |
NIL
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed case of Acute Pancreatitis |
|
| ExclusionCriteria |
| Details |
Proven cases of Chronic Pancreatitis.
Diagnosed case of Pancreatic Neoplasm
Patients with Immunosuppressive state
Patients with known Co-morbidities eg. COPD, Renal Impairment
Pregnant Females
Traumatic Pancreatitis with other visceral injuries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy evaluation of the BISAP and APACHE II scoring systems in differentiating mild-moderate vs severe acute pancreatitis. |
severity assessment at time of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To document the etiology of Acute Pancreatitis |
based on clinical evaluation & investigation at time of admission (Baseline) |
| To collect demographic data of Acute Pancreatitis |
based on admission data |
| To evaluate mortality in Acute Pancreatitis |
within the duration of hospitalization |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [parthsatani7019@gmail.com].
- For how long will this data be available start date provided 01-03-2024 and end date provided 31-12-2025?
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
|
This study aims at evaluating BISAP and APACHE II scoring systems in patients of Acute Pancreatitis on admission and assessing severity of Acute Pancreatitis. This data will provide valuable insight in assessment of progression of disease and improving treatment strategies and enhancing patient outcomes in management of acute pancreatitis. In this study, we aim to deliver deeper into the epidemiology of Acute Pancreatitis in Central India. This project seeks to contribute to the existing knowledge base and inform evidence-based practices for the prognostic accuracy of scoring systems in Acute Pancreatitis. |