Rajiv Gandhi University of Health Sciences, Karnataka s31

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA , BENGALURU.

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

“ASSESSMENT OF ACCURACY & PREDICTABILITY OF PANC 3 SCORING SYSTEM OVER APACHE II IN ACUTE PANCREATITIS – A PROSPECTIVE STUDY”

1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA. BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

2 1. Name of the Candidate Dr.VIKRAM.H.V and Address ROOM NO GOO3, PG HOSTEL (in block letters) ESI POST GRADUATE INSTITUTE OF MEDICAL SCIENCE & RESEARCH, RAJAJINAGAR, BENGALURU.

2. Name of the Institution ESI POST GRADUATE INSTITUTE OF MEDICAL SCIENCE & RESEARCH RAJAJINAGAR, BENGALURU-10

3. Course of study and subject GENERAL SURGERY

4. Date of Admission to course 1st JUNE

5. Title of the Topic “ASSESSMENT OF ACCURACY & PREDICTABILITY OF PANC 3 SCORING SYSTEM OVER APACHE II IN ACUTE PANCREATITIS – A PROSPECTIVE STUDY”

3 Brief Resume of the intended work :

6.1 Need for the study

The clinical course of Acute Pancreatitis (AP) varies from a mild transitory form to a severe necrotising disease. Most of these episodes are mild and spontaneously subsiding with in 3 to 5 days1, 2. In contrast, Severe Acute Pancreatitis (SAP) occurring in around 15 – 20 % of all cases3 , mortality can range between 10 to 85 % across various centres and countries. In such a situation we need an indicator which can predict the outcome of an attack, as severe or mild, as early as possible and such an indicator should be sensitive and specific enough to trust upon. World wide, different indicators have been given the status of “Prognostic Importance” and many of such indicators have different sensitivity and specificity in predicting the outcome of an attack of AP. “The Search for the Best Indicator is Still On”. Experts have also tried to combine such indicators to fit them into a scoring system, rather ‘Systems’ and when such indicators are combined the predictive value becomes maximum.

There are several such scoring systems (Ransons, Imrie, BISAP AUC, APACHE II, and APACHE III) which have their own statistical importance and prediction of outcome in AP, forecasting patients at risk of SAP4. Most of such systems needs advanced laboratory requirements, take greater then 48hrs to enable full severity stratification and cumbersome.

PANC 3 scoring developed by Brown A et. al of Harvard Medical School as claimed by authors is such a scoring system which is easy to apply, needs facilities of a basic hospital and is as good as other scoring systems in predicting the outcome of an attack of AP.

With this background we, are evaluating the predictive value of PANC3 scoring in comparison to APACHE II, which is the most widely accepted scoring system in predicting the outcome of an acute attack of Pancreatitis5.

6.2 Review of literature :

4 Acute Pancreatitis according to standard Atlanta Classification 1992 is defined as “An Acute Inflammatory Process of the Pancreas with variable involvement of other regional tissue or remote organ system, associated with raised pancreatic enzyme levels in blood and/or Urine”. Atlanta Symposium 1992 also graded the attack based on severity into, Mild Acute Pancreatitis and Severe Acute Pancreatitis. Atlanta symposium also used Ransons > 3 or APACHE > 8 as predictors of severity of an acute attack of pancreatitis. Organ failure by definition means 1) Systolic BP of <90 mm Hg for Cardio vascular system, 2) A Creatinine of greater than 2.0 mg/dl for Renal System, 3) A loss of greater than 500 mL of blood form the gastrointestinal tract within a 24-hour period, 4) An arterial PaO2 of less than 60 for Respiratory System.

Mortality in severe pancreatitis can be as high as 85 % noted by studies of Tenner’s et, al 7 or 99% as noted by Mayerle et, al 8. But usually mortality ranges from 10% to 85% between various countries and centres 5.

Studies have suggested that we can predict the outcome of an Attack by using different clinical & biochemical parameters, which show different specificity and sensitivity in predicting the future of an attack9. Such parameters/indices can be combined in various combinations to maximise the predictive value.

Ransons criteria was first developed for a retrospective study of one institution experience with pancreatitis , critics of Ransons score pointed that it needs 48hrs to tabulate the total score and that may be a valuable time.

APACHE scoring system involving APACHE II, APACHE III and recent addition of APACHE II-O was originally tabulated to assess the critically ill patients in ICU setup 5, which has been adopted for predicting the severity of Acute Pancreatitis. Studies also suggest that 8hr APACHE II has more predictive value than Score at Admission11. But APACHE system (APACHE II) which is widely accepted for evaluation of Acute Pancreatitis needs sophisticated laboratory facility and expertise to calculate the score. Once score is calculated it’s easy to interpret, however practical problem arises when one has to tabulate 12 odd criteria of APACHE II to all patients of Acute Pancreatitis, which means unnecessarily subjecting the patients to investigations, which is also not so cost effective.

PANC 3 scoring system is a very simple, rapid, accurate and performed at emergency department of almost all hospitals. It is claimed to be as good as APACHE

5 II in predicting the outcome of an attack of Acute Pancreatitis12.

PANC 3 scoring system involves inclusion of three very simple parameters which are

1)Hematocrit of > 44mg/dl, 2) Body Mass Index of >30 Kg/m2 and 3) Chest X rays which reveals Pleural Effusion.

According to study conducted by Brown A et. al for assessment of predicting severity on presentation in Acute Pancreatitis. They found out that, sensitivity analysis of all three criteria put together was 99%. When pre-test probability of disease varied from 12 – 25%.

Hematocrit is a reflector of hemoconcentration and in Acute Pancreatitis has positive predictive value of 87% with specificity of 98% 13.

Body Mass Index is also a good predictor individually as assesed by Martinez J, Johnson C E et. al, they showed that SAP was significantly more frequent in obese patients. Having an odds ratio of 2.9 14.

Ocampo C et. al have stated in their study that Pleural Effusion is superior to multiple factor scoring system in predicting Acute Pancreatitis outcome by likelihood positive ratio of 16.1 for predicting total complication which is statistically significant 14.

Keeping in view, this study will be a contribution towards such an effort for finding a rapid, accurate and practically feasible scoring system for triaging patients with Acute Pancreatitis and make the Hospital prepared to accept Severe Acute Pancreatitis.

6 6.3 Objectives of the study : 1)To assess the accuracy of PANC 3 scoring system in predicting Severity in an attack of acute pancreatitis. 2)To evaluate predictability of PANC 3 scoring with APACHE II Scoring system .

Material and methods : 7.1 Source of data : This study will be conducted in dept of GENERAL SURGERY, ESI POST GRADUATE INSTITUTE OF MEDICAL SCIENCE & RESEARCH RAJAJINAGAR, BENGALURU-10 , over a period of one year. All Consecutive patients presenting to the surgical emergency will be included in the study with following criteria. Clinically any patient presenting with abdominal pain and vomiting with raised Serum Amylase levels more than three times the upper limit of normal or Serum Lipase of more than four times the upper limit of normal is considered as Acute Pancreatitis. Severe Acute Pancreatitis is an attack of Acute Pancreatitis associated with organ failure and/or local complications such as necrosis of more than one third of pancreatic tissue, abscess or pseudocysts. Atlanta Symposium 1992 also considered Ransons > 3 or APACHE II > 8 as predictors of severity of an acute attack of pancreatits. Organ failure by definition means, 1) Systolic BP of <90 mm Hg for Cardio Vascular System 2) Creatinine of greater than 2.0 mg/dl for Renal System 3) Loss of greater than 500 mL of blood from the Gastrointestinal tract within a 24hr period 4) Arterial PaO2 of less than 60 for Respiratory System

Sample size : 7 Number of Patients Studied : Minimum of 60 Duration of Study : 1 year

Study Design: A Prospective study

Inclusion criteria : 1)Case with clinical history of abdominal pain and an increased Level of pancreatic enzymes suggestive of Acute Pancreatitis 2)Onset of pain abdomen <48 hrs. 3)Age >15 years

Exclusion criteria : 1)Patients with other co-morbid conditions like cardiac failure ,liver failure, renal failure or any lung pathology. 2)Attack of Acute on Chronic Pancreatitis. 3)Recurrent attack of Acute Pancreatitis of the previous history of Complications like pseudocyst , pancreatic abscess etc.

7.2 Method of collection of data:

Patient after thorough clinical examination and confirmation of presence of Acute Pancreatitis will undergo the following Biochemical and Radiological investigations General Investigations:

1) Hemogram- Hb, TLC, DLC, Platelet Counts 2) Blood Sugar 3) Serum Electrolytes 4) RFT 5) LFT 6) ECG

8 Investigations to evaluate PANC 3 score: 1) Hematocrit 2) X-ray Chest / Ultrasonography for Pleural Effusion 3) Calculation of Body Mass Index

Investigations to determine APACHE II score: 1) ABG with Electrolytes 2) Serum Creatinine 3) Serum LDH All these investigations will be done in ESI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCE AND RESEARCH, at the time of Admission and relevant other investigations will be repeated after 48 hrs.

Each patient will undergo above investigations, with those results PANC 3 score is calculated, in the same patient APACHE II is also calculated. Patient will be treated according to standard treatment protocol. Which are? 1) Intra Venous Fluids 2) Analgesics 3) Antibiotics 4) Nasogastric Aspiration in patients who have Vomiting and Nausea 5) Surgery if indicated.

Statistical analysis : The results of test as patient developed Sever Acute Pancreatitis or not will be tabulated and the final result will be evaluated statistically using Mc Neimer Chi Square Test for discrete variables and Student “T” test for continuous variables. P value less than or reveal to 0.05 will be taken as significant.

9 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. Yes

Complete blood count Hematocrit Coagulation Profile Blood Sugar Serum Electrolytes LFT RFT Serum amylase Serum lipase Arterial blood gas analysis ECG Chest Xray Abdominal Xray USG CT scan MRI

7.4. Has ethical clearance been obtained from your institution in case of 7.3? Yes

10 8. References : 1) Isenmann R, Berger H. “Natural History of Acute Pancreatitis and the role of Infection”. Bailiers Best Pract clin gastroenterol 1999; 13: 291-301.

2) Klar E, Werner J. “New pathophysiological findings in Acute Pancreatitis”. Chirurgia 2000; 71: 253-64.

3) Uhl W, Warshaw A, Imrie C. “IAP Guidelines for the Surgical Managaement of Acute Pancreatitis”. Pancreatology 2002; 2: 565-73.

4) Mc Kay C J, Imrie C W, “Staging of Acute Pancreatitis. Is it important?”. Surg Clin North Am 1999; 79: 733-43.

5) Wilson C, Heath D I, Imrie C W. “Prediction of outcome in Acute Pancreatitis. A comparative study of APACHE II, Clinical Assessment and Multiple Factor Scoring Systems”. Br J Surg 1990; 77: 1260-64.

6) T L Bollen, C. Van Santvoort. “The Atlanta Classification of Acute Pancreatitis revisited”. British J of Surg 2008; 95: 6-21.

7) Tenner S, Sica G, Huges M. “Relationship of Necrosis to Organ failure in Severe Acute Pancreatitis”. Gastroenterology 1997; 113: 899-903.

8) Mayerle J, Hlouschek V, Lerch M M. “Current Management of Acute Pancreatitis”. Nat Clin Pract Gastroenterol Hepatol 2005; 2: 473-83.

9) Fan S T, Lai E C, Mok F P, LOCM, Zheng S S, Wong J. “Prediction of the Severity of Acute Pancreatitis”. Am J Surg 1993; 166: 262-68.

10) Williams S, Simms H H. “prognostic usefulness of Scoring Systems in Critically ill patients with Severe Acute Pancreatitis”. Critical Care Med 2000; 28(8): 3124-5.

11 11) Arif A Khan, M D; Dilip Parekh, M D; Young Cho, M D;. “Improved prediction of outcome in patients with SAP by the APACHE II Score at 48 hrs after Hospital Admission compared with the APACHE II Score at Admission”. Arch Surg 2002; 137: 1136-40.

12) Brown A, James-Stevenson Tm, Dyson T, Grunkenmeier D. “The Panc 3 Score: a rapid and accurate test for predicting severity on presentation in Acute Pancreatitis”. J. Clin Gastroenterol 2007 oct; 41(9): 855-8.

13) Brown A, Orav J, Banks P A. “Hemoconcentration is an early marker for organ failure and Necrotising Pancreatitis”.Pancreas 2000; 20: 367-72.

14) Martinez J, Johnson C D, Sanchez-paya J, “Obesity has a definitive risk factor of Severity and Mortality in Acute Pancreatitis: an updated meta analysis”. Pancreatology 2006; 6(3): 206-9.

15) Ocampo C, Silva W, Zandalanzini H. “Pleureal Effusion is Superior to Multiple Factor Scoring System in predicting Acute Pancreatitis outcome”. Acta Gastroenterol Latinoam(in Spanish). 2008; Mar: 38(1): 34-42.

PROFORMA

The following proforma will be 12used as a thesis case record. 9. Signature of candidate

10 Remarks of the guide 1)As there are number of pancreatitis cases handled in our hospital there is a good scope for the study. 2)Also we need a simpler assertment protocol to evaluate severity of disease which is cost effective and easily done. 11 Name & Designation of (in block letters) 11.1 Guide DR.SHRIDHAR.M, PROFESSOR, DEPT.OF GENERAL SURGERY, ESI-PGIMSR,RAJAJINAGAR, BENGALURU.

11.2 Signature

11.3 Co-Guide DR.SATYANARAYAN.V, ASSOCIATE PROFESSOR, DEPT. OF GENERAL SURGERY, ESI-PGIMSR,RAJAJINAGAR,BENGALURU.

11.4 Signature

11.6 Head of department DR LAKKANNA.S HOD & PROFESSOR, DEPT.OF GENERAL SURGERY, ESI-PGIMSR,RAJAJINAGAR, BENGALURU 11.7 Signature

12 12.1. Remarks of the Chairman & Principal

12.2. Signature.