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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 


 
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