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CTRI Number  CTRI/2023/07/055465 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Comparison between Japanese Severity Score (JSS) and APACHE 2 in predicting the severity of Acute Pancreatitis 
Scientific Title of Study   A prospective study comparing the efficacy of Japanese Severity Score(JSS) and APACHE 2 in predicting the severity of Acute Pancreatitis 
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 Bhagyashree Nayker 
Designation  DNB Emergency Medicine Resident 
Affiliation  The Signature Hospital 
Address  The Signature Hospital,Emergency medicine Department, DNB emergency medicine division,DNB room 1, Near BPTP, Sector 37D, Gurugram, Haryana

Gurgaon
HARYANA
122001
India 
Phone  8511147794  
Fax    
Email  naykerbhagyashree@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhagyashree Nayker 
Designation  DNB Emergency Medicine Resident 
Affiliation  The Signature Hospital 
Address  The Signature Hospital,Emergency medicine Department, DNB emergency medicine division,DNB room 1, Near BPTP, Sector 37D, Gurugram, Haryana

Gurgaon
HARYANA
122001
India 
Phone  8511147794  
Fax    
Email  naykerbhagyashree@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Arora 
Designation  MS General Surgery Consultant 
Affiliation  The Signature Hospital 
Address  The Signature Hospital,Emergency medicine Department, DNB emergency medicine division,DNB room 1, Near BPTP, Sector 37D, Gurugram, Haryana

Gurgaon
HARYANA
122001
India 
Phone  8376950309  
Fax    
Email  dnb.signaturegurgaon@gmail.com  
 
Source of Monetary or Material Support  
The Signature Hospital, Sector 37 D,Gurugram,Harayana 122001 
 
Primary Sponsor  
Name  The Signature Hospital 
Address  Near BPTP, Sector 37 D ,Gurugram,Harayana,122001 
Type of Sponsor  Private hospital/clinic 
 
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 Bhagyashree Nayker  The Signature Hospital  Emergency medicine department, DNB Emergency medicine division, DNB Room no 1, Gurugram Haryana
Gurgaon
HARYANA 
8511147794

naykerbhagyashree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Park Hospital-Ethics Committee  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Characteristic acute abdominal pain
2.Patient with raised amylase and lipase levels >3times the normal value
3.USG abdomen demonstrating changes consistent with acute pancreatitis.
4.Adequate history of presentation
5.Both sexes
 
 
ExclusionCriteria 
Details  1.Age <16 years
2.Traumatic pancreatitis
3.Hereditary pancreatitis
4.Iatrogenic Pancreatitis
5.Incomplete data of presenting illness
6.Proven cases of chronic pancreatitis
7.Doubtful Diagnosis
8.Acute on chronic pancreatitis
9.Patient with Chronic Liver Disease (CLD) with pancreatitis and Cirrhosis
10.Acute Pancreatitis patients with organ failure at or within 24 hours of presentation
11.Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assist in Triage & appropriate level of care   At the time of Admission 
 
Secondary Outcome  
Outcome  TimePoints 
Initiation of Proactive early Management if required  At the time of Admission 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   28/07/2023 
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="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 - NO
Brief Summary  

Acute Pancreatitis (AP) is common and one of the most potentially dangerous disorder with a highly variable clinical course.  

The clinical course of Acute Pancreatitis (AP) varies greatly between patients from a mild pancreatic inflammation treated conservatively to a severe disease resulting in multiple organ failure, infected pancreatic necrosis and mortality. Severity of Acute Pancreatitis is linked to presence of Systemic Organ Dysfunctions and/or pancreatitic necrosis.

Acute Pancreatitis can be classified as mild and severe form. Mild acute pancreatitis is characterized by interstitial edema of the gland in whom short term remission is achieved. Whereas in the severe form, there is presence of pancreatic necrosis, severe systemic inflammatory response and multiorgan failure which can lead to death.

Hence it is of utmost importance to identify the patients at risk for organ failure early in the disease course during admission that will assist in triage, appropriate level of care and initiation of aggressive early treatment that will likely decrease mortality.

Many severity scoring systems have been developed for early detection of SAP (Severe Acute Pancreatitis) over the years.

The Ranson Score represented a major advancement in evaluation of disease severity of AP in early years. Since then, many other scoring systems have been made for assessing the same as follows:

Acute Physiology and Chronic Health Evaluation 2 (APACHE-2)

Modified Glasgow Score (MGS)

CT Severity Index (CTSI)

Pancreatis Outcome Prediction (POP)

Harmless Acute Pancreatis Score (HAPS)

Bedside Index for Severity in Acute Pancreatitis (BISAP)

MOSS score

SIRS Score

Japanese Severity Score (JSS)

The two most popular criteria used to be Ranson and Glasgow scoring system. Ranson criteria has been used for a long time; as it requires a complete assessment after 48 hours for the score to be calculated, so results are available late.

The (APACHE II) is widely used in predicting the severity of acute pancreatitis. The major advantage of the APACHE II scoring system, as compared with the other systems, is that it can be used in monitoring the patient’s response to therapy while Ranson and Glasgow scales are mainly meant for assessment at the presentation.

It requires the collection of a large number of parameters which makes it Complex and cumbersome.

BISAP and HAPS score are recently developed scores which takes into account comparatively fewer parameters and can be performed bedside within initial few hrs.         

These scoring systems incorporate physiologic, laboratory, and occasionally radiographic parameters by using cut off values.

Recently, attention has also been focused on the role of individual laboratory parameters in assessing severity such as blood urea nitrogen (BUN), Creatinine, Procalcitonin etc.

Recently, in 2008 an overall revision was made to the severity assessment in Japanese guidelines and a New Japanese Severity Score (JSS) was developed for the assessment of severity of Acute Pancreatitis.

In the new severity assessment criteria (JSS), the diagnosis of severe acute pancreatitis can be made according to nine prognostic factors and/or the computed tomography (CT) grade, determined on the basis of contrast-enhanced CT.

It also recommends that severity assessment is made first on the basis of prognostic factors that can be assessed at any time and everywhere, and that contrast-enhanced is performed in cases in which pancreatic necrosis is suspected by plain-CT.

It is also recommended that in cases where worsening of disease is suspected, CECT is performed even if prognostic factor score is less than 2 points.

This study intends to study the accuracy of Prognostic factor of JSS and APACHE-2 to assess the severity of Severe Acute Pancreatitis (SAP) in the Emergency Department (ED).

    

  AIM AND OBJECTIVES OF THE STUDY:

1.To evaluate the ability of Prognostic factor in Japanese Severity Score (JSS) to predict severity in acute pancreatitis patients from our hospital

2.To evaluate the ability of the APACHE-2 score to predict which patients are at risk for development of organ failure, and pancreatic necrosis.

3.To compare efficacy of Prognostic Factor in JSS score and APACHE-2 Score in predicting severity of Acute Pancreatitis.


I want to do this study to compare the JSS Score - Prognostic factor and APACHE-2 in predicting the Severity of Acute pancreatitis to find out which is more efficacious at the time of admission.

As this study has not been done in this part of India, I want to go forward with this study. 


 
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