A study on a newer severity scoring system for Acute Pancreatitis

Not yet recruiting

Conditions: Acute pancreatitis, unspecified,

Registration Number: CTRI/2023/08/056372

Lead Sponsor: CDSIMER

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 Crohnâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-The use of antibiotics, initiation of total parenteral nutrition, and	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
development of local complications are recorded; the latter being defined	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
as pseudocysts, necrotic collections, or walled off pancreatic necrosis .	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
-Pancreatitis episode can be scored as mild, moderately severe, & severe	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
according to the revised Atlanta classification .	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
failure score of2 or above.	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
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
-Development of organ failure will be defined as modified Marshall organ	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 Measures

Name	Time	Method
-Need for surgery	-Mortality

Trial Locations

Locations (1): CDSIMER
🇮🇳
Rural, KARNATAKA, India
CDSIMER
🇮🇳Rural, KARNATAKA, India
Dr Padma Kannan
Principal investigator
9940104958
padmakannan93@gmail.com