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CTRI Number  CTRI/2023/03/050564 [Registered on: 10/03/2023] Trial Registered Prospectively
Last Modified On: 28/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role of Red Cell Distribution Width to Platelet ratio which can be obtained from a Blood test (CBC) to differentiate the severe cases of Acute Pancreatitis from mild cases in the early phase of the attack to provide aggressive treatment to severe cases from the initial time.  
Scientific Title of Study   RPR(Red Cell Distribution Width to Platelet ratio) an early prognostic marker in cases 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  Jyoti Bansal  
Designation  Post Graduate  
Affiliation  Kasturba Medical College, Manipal 
Address  3rd Floor, Department of General Surgery, Smt. Sharda Madhav Pai, OPD Building, Kasturba Hospital,Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9027126809  
Fax    
Email  jyoti.bansal@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena L Karanth 
Designation  Professor and Head of Unit -2 
Affiliation  Kasturba Medical College, Manipal 
Address  3rd Floor, Department of General Surgery, Smt. Sharda Madhav Pai, OPD Building, Kasturba Hospital, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9845417715  
Fax    
Email  veena.karanth@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Veena L Karanth 
Designation  Professor and Head of Unit -2 
Affiliation  Kasturba Medical College, Manipal 
Address  3rd Floor, Department of General Surgery, Smt. Sharda Madhav Pai, OPD Building, Kasturba Hospital, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9845417715  
Fax    
Email  veena.karanth@manipal.edu  
 
Source of Monetary or Material Support  
Department of General Surgery Department of Gastroenterology Kasturba Medical College, Manipal, Udupi Karnataka- 576104 
 
Primary Sponsor  
Name  Kasturba Medical College, Manipal 
Address  Kasturba Medical College, Manipal, Udupi Karnataka- 576104  
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 Veena L Karanth  Kasturba hospital, Maniapl  3rd floor, Department of General Surgery , OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9845417715

veena.karanth@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital , Institutional Ethics Committee-2  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, (2) ICD-10 Condition: K860||Alcohol-induced chronic pancreatitis, (3) ICD-10 Condition: K851||Biliary acute pancreatitis, (4) ICD-10 Condition: K853||Drug induced acute pancreatitis, (5) ICD-10 Condition: K850||Idiopathic acute pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) case of Acute Pancreatitis presented to Kasturba Hospital, Maniapl.
2) patients who are 18 years and above.
 
 
ExclusionCriteria 
Details  1) Patient with pre existing pancreatitis (k/c/o chronic pancreatitis and pancreatic cancers)
2) Already included patient presented with recurrent attack will not be included again.
3) Patient has undergone any kind of surgery of pancreas. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients will be divided on the basis of severity: based on (REVISED ATLANTA CLASSIFICATION)
• In the two group of patients, commonly used scores will be used to measure the severity of acute pancreatitis at the time of admission
• Scores that will be used for comparison are:
1) APACHE 11
2) BISAP

Study will help to find a way to distinguish between severe cases of acute pancreatitis from milder cases in early phases Acute Pancreatitis and to proceed with the management accordingly.  		 From the time of Admission till Discharge or death time  
 
Secondary Outcome  
Outcome  TimePoints 
Study will help to find a way to distinguish between severe cases of acute pancreatitis from milder cases in early phases Acute Pancreatitis and to proceed with the management accordingly.   From the time of Admission till Discharge or death time  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   22/03/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Diagnosed cases of Acute Pancreatitis being admitted  in Department of General Surgery and Department of Gastroenterology , Kasturba Hospital, Manipal will be recruited in this study. Red cell distribution width to platelet ratio from Complete Blood Count will be calculated during the early phase of disease and will be compared with BISAP and APACHE II scoring in knowing the prognosis of acute pancreatitis in early phases. 
Patients will be followed up till the time the time of discharge or death. The values obtained will be analysed and using various statistical tests following which conclusion will be made if CBC can be used for determining the prognosis of acute pancreatitis. Since CBC is a routine investigation and RPR ( Red cell distribution width to platelet ratio) is easy to calculate , this study will provide us with a marker from routine investigation to know the prognosis. 
 
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