FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056372 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 09/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study on a newer severity scoring system for Acute Pancreatitis 
Scientific Title of Study   A Comparative Study on PASS (Pancreatic Activity Scoring System) and BISAP (Bedside Index of Severity in Acute Pancreatitis) scores in the prediction of 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  Padma Kannan 
Designation  Senior Resident 
Affiliation  CDSIMER 
Address  Room 4, Department of General Surgery, Chandramma Dayanand Sagar Institute of Medical Education and Research, Devarakkagalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka

Bangalore Rural
KARNATAKA
562112
India 
Phone  9940104958  
Fax    
Email  padmakannan93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Padma Kannan 
Designation  Senior Resident 
Affiliation  CDSIMER 
Address  Room 4, Department of General Surgery, Chandramma Dayanand Sagar Institute of Medical Education and Research, Devarakkagalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka


KARNATAKA
562112
India 
Phone  9940104958  
Fax    
Email  padmakannan93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Padma Kannan 
Designation  Senior Resident 
Affiliation  CDSIMER 
Address  Room 4, Department of General Surgery, Chandramma Dayanand Sagar Institute of Medical Education and Research, Devarakkagalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka


KARNATAKA
562112
India 
Phone  9940104958  
Fax    
Email  padmakannan93@gmail.com  
 
Source of Monetary or Material Support  
CDSIMER, Devarakkagalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka 562112 
 
Primary Sponsor  
Name  CDSIMER 
Address  CDSIMER, Devarakkagalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka 562112 
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 Padma Kannan  CDSIMER  Department of General Surgery, CDSIMER, Devarakkagalahalli, Harohalli, Kanakapura Rd, Kanakapura, Karnataka 562112
Bangalore Rural
KARNATAKA 
9940104958

padmakannan93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CDSIMER IEC  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  BISAP score  Comparing the prediction of severity of acute pancreatitis by the newer PASS score as compared to the standard BISAP score 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients with diagnosis of acute pancreatitis admitted in CDSIMER
-Patients with characteristic epigastric pain with elevated levels of serum lipase and/or amylase 3 times of the standard values
- Patients with characteristic epigastric pain with Ultrasonography or CT of abdomen within first 7 days of hospitalization demonstrating changes
consistent with acute pancreatitis 
 
ExclusionCriteria 
Details  Patients who are less than 18 years of age.
-Patients who do not consent to participate in the study
-Patients discharged against medical advice
- Patients transferred in from outside tertiary centre, after initial treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-The use of antibiotics, initiation of total parenteral nutrition, and
development of local complications are recorded; the latter being defined
as pseudocysts, necrotic collections, or walled off pancreatic necrosis .
-Pancreatitis episode can be scored as mild, moderately severe, & severe
according to the revised Atlanta classification .
-Development of organ failure will be defined as modified Marshall organ
failure score of2 or above.
These outcomes shall be used to assess the effectiveness of PASS score as compared to the BISAP score in predicting the severity of acute pancreatitis 
Patient shall be evaluated at admission, every 12 hours then on & at the time of discharge.
This prospectively ascertained data set shall be used to calculate the
PASS score at the time of admission & every 12 h during
the hospitalization & at discharge.
BISAP score shall be calculated at admission 
 
Secondary Outcome  
Outcome  TimePoints 
-Need for surgery
-Mortality 
Patient shall be evaluated at admission, every 12 hoyrs then on & at the time of discharge.
 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   19/08/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is a clinical puzzle, that continues to have clinicians and
researchers befuddled and searching for more viable solutions. While
patients that are assumed to be mild cases detoriate rapidly in an
unexpected manner, the outcomes for cases deemed serious present with
varying in-hospital courses: that include the development of complicaitons,
ICU stay and mortality. Such a variable and unpredictable clinical course
has encouraged researchers to identify markers of serious disease.
Interventional studies have targeted patients with predicted severe
pancreatitis. However, predicted severe pancreatitis has varying definitions
ranging from various APACHE scores to C-reactive protein levels to
clinical findings, such as abnormal chest roentgenography. Unfortunately,
diversity of clinical presentations makes it challenging to identify which
groups of patients benefit from specific therapy.
Additionally, while objective acute pancreatitis outcomes such as death are
fortunately rare this necessitates the use of surrogate measures such as
clinical improvement or changes in cytokine levels as study endpoints. The
use of scoring systems that predict severity of disease have predominated
in the acute pancreatitis field. However, there has been a limitation in
quantitative scoring systems that encompass the overall physiologic status
of the patient for studies. The study of other disease states including
inflammatory bowel disease has benefited from the development of
quantitative scoring systems such as the Crohn’s Disease Activity Index
that can be used to monitor the disease activity during its course.
To address this need, a group of international experts recently developed
the dynamic acute Pancreatitis Activity Scoring System (PASS). A key
step in validating any new disease assessment tool is to evaluate the
relationship between the scoring system and clinical outcomes.
Outcomes that are deemed crucial in acute pancreatitis include the
development of transient or persistent organ failure (moderately severe and
severe pancreatitis) as well as local complications, such as pseudocysts and
walled off pancreatic necrosis.

Our aim is to compare the PASS score and an already established BISAP
score in the prediction of severity of acute pancreatitis based on pertinent
clinical outcomes.
India has one of the highest cases of acute pancreatitis worldwide
(highest worldwide incidence as well as mortality in 2019*) and
prevalence rate for Pancreatitis in India is 7.9 per 100,000. Prevalence
rate for men and women 8.6 and 8.0 per 100,000 respectively in India.
If the PASS score is indeed as helpful as visualized in predicting which
patients have a higher chance of severe disease, it can be included in our
institutional protocols for the management of acute pancreatitis and early
identification of sick patients will help direct treatment more effectively
and reduce the morbidity and mortality, benefiting the patient.
 
Close