| CTRI Number |
CTRI/2024/06/069632 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON OF SCORING SYSTEMS FOR SEVERE ACUTE PANCREATITIS IN INDIAN POPULATION |
|
Scientific Title of Study
|
Comparison of New scoring system with existing scoring systems for severe acute pancreatitis in Indian population |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
jatin agarwal |
| Designation |
junior resident |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
department of general medicine,kasturba hospital,manipal,udupi
Udupi KARNATAKA 576104 India |
| Phone |
9000100491 |
| Fax |
|
| Email |
jatinagarwal13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ganesh shetty |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
department of general medicine,kasturba hospital,manipal,udupi
Udupi KARNATAKA 576104 India |
| Phone |
9481955563 |
| Fax |
|
| Email |
ganesh.shetty@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Ganesh shetty |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
department of general medicine,kasturba hospital,manipal,udupi
Udupi KARNATAKA 576104 India |
| Phone |
9481955563 |
| Fax |
|
| Email |
ganesh.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Medical College, Manipal, Karnataka- 576104, India |
|
|
Primary Sponsor
|
| Name |
Dr Jatin agarwal |
| Address |
Kasturba Hospital,Manipal,Udupi district, karnataka- 576104, India |
| Type of Sponsor |
Private 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 Jatin Agarwal |
Kasturba Hospital, Manipal |
Department of General Medicine, Kasturba Hospital, Manipal, Udupi district, Karnataka- 576104, India Udupi KARNATAKA |
9000100491
jatinagarwal13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
all patients more than 18years with severe acute pancreatitis |
|
| ExclusionCriteria |
| Details |
Patients with chronic pancreatitis
2) Patients with malignancy and metastasis
3) Patients with chronic kidney disease
4) Patients with Chronic liver disease
5 )Patients with congestive cardiac failure
6) Patients with acute coronary syndrome
7) Pregnant patients
8) Trauma
9) Anemia
10) Patients with Diabetes Mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of different scoring systems for severe acute pancreatitis |
31st march 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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)
|
07/07/2024 |
| 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="0" Months="0" 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 - NO
|
|
Brief Summary
|
Conventional scoring systems are based on either the biochemical and clinical criteria, or imaging features Ranson’s score comprises 11 indicators that must be evaluated at admission and 48hours after admission, respectively. However, some of these indicators are not collected routinely in the early stage of AP, making early prediction difficult BISAP score comprises 5 indicators to predict the mortality of AP within 24hours of admission. It is easy to use but has low sensitivity for prediction of SAP. MCTSI was proposed based on the CT severity index and does not takes in to consideration the clinical and biochemical parameters The new scoring system uses biochemical markers, heart rate and imaging features. Earlier studies were conducted in Chinese population and now we want to assess the accuracy of the new scoring system in Indian population
description After obtaining permission from the institutional ethics committee, patients will be selected based on the above inclusion and exclusion criteria and recruited into the study after taking informed written consent, strict confidentiality will be maintained All patients will be evaluated using detailed history, clinical examination and necessary laboratory investigations including complete blood count, CRP, LDH, renal function and liver function tests including serum albumin levels, and the same will be documented. The collected data, also including imaging features, will be tabulated based on the respective criteria used in the different scoring systems used previously, i.e., RANSON, BISAP, MCTSI and the new Chinese Simple Scoring system. The quantitative data will be summarized in an Excel sheet and analysed. The correlation of the different scoring systems with the clinical outcome of the patient will be done, including parameters like duration of hospital stay and mortality. Scores included in the study are 1. Chinese Simple Scoring System 2. BISAP score 3. Ranson’s Score 4. MTCSI |