A Prospective Comparative Study of Bedside Index Severity Score and Harmless Acute Pancreatic Score for Prognosticating the Severity of Acute Pancreatitis

Introduction

Acute pancreatitis, an extremely common medical condition encountered by patients who actively seek medical attention in various healthcare facilities, identified by the sudden onset of severe abdominal pain and a significant rise in the levels of amylase or lipase found in the serum. The fundamental mechanism of underlying pathological process of pancreatitis is hypothesised to be the untimely activation of pancreatic enzymes within the pancreatic tissue itself, which then induces the phenomenon of autodigestion. This autodigestion process, in turn, leads to the extensive damage of the acinar cell, thus impairing the normal secretion of zymogen granules or causing damage to the duct epithelium. Consequently, the impairment in the enzymatic secretion hinders the normal flow of pancreatic enzymes, ultimately triggering the development of acute pancreatitis.¹

Gallstone which causes pancreatitis, the most frequently observed type accounting for 40% of acute pancreatitis cases in individuals aged between 50 and 70 years with symptomatic gallstone disease, has a prevalence ranging from 3% to 8%. As per the obstructive theory, pancreatic damage occurs due to excessive pressure in the pancreatic duct. In spite of pancreatic duct obstruction, the continuous secretion of pancreatic juice causes an increase in intraductal pressure. On the other hand, the secondary reflux theory suggests that stones become impacted in the ampulla of Vater, forming a common channel that allows the reflux of bile salts into the pancreas. Animal models have shown that bile salts directly cause acinar cell necrosis by increasing the concentration of calcium in the cytoplasm. However, this has not been conclusively proven in humans.²

Alcohol-induced acute pancreatitis is the second most common cause of the disease globally, accounting for 35% of acute pancreatitis cases. However, it is worth noting that only 5% to 10% of individuals who consume alcohol develop acute pancreatitis. It is more common in young men, between the ages of 30 and 45 years, compared to women. Antecedent factor to ethanol-induced pancreatitis includes heavy ethanol abuse (at least 100 g/day for a minimum of five years), smoking, and genetic predisposition.³

Pancreatitis is generally determined by the examination of clinical manifestations and the identification of increased levels of serum amylase and lipase. Although the utilization of imaging techniques is not always mandatory, it can be employed for the purpose of validating the diagnosis or excluding alternative pathologies or examining any probable complications that may have arisen.

The patients with acute pancreatitis mostly present with non-severe forms of the condition, which can be effectively managed through conservative measures and eventually result in complete recovery. Only 15% of patients demonstrate severe variants of acute pancreatitis, a condition characterized by inflammation and walled-off pancreatic necrosis. This initial stage is followed by the manifestation of symptoms associated with Systemic Inflammatory Response Syndrome (SIRS), which has the probability to progress into Multiorgan dysfunction syndrome (MODS) within a span of 7 to 10 days. It is worth noting that around half of the individuals diagnosed with severe pancreatitis are likely to develop complications, such as Acute respiratory distress syndrome (ARDS) or MODS, within the first week of onset. These complications further contribute to the complexity of the condition and necessitate timely and appropriate intervention strategies for optimal patient management. The severity of acute pancreatitis underscores the importance of early identification and effective treatment approaches to mitigate the risk of adverse outcomes and enhance patient prognosis. While the majority of patients with acute pancreatitis experience milder forms, understanding the potential for progression and the associated complications is vital in guiding clinical decision-making and optimizing patient care. The mortality rate among patients with MODS ranges from 30% to 100%. These individuals require immediate resuscitation and intensive treatment to prevent the development of multiorgan and respiratory failure. Some patients may also require surgical procedures such as retroperitoneal drainage and necrosectomy.

Materials and Methods

In this study, the inclusion of criteria were based on the acquisition of written informed consent, ensuring that the participants were fully aware of the nature and purpose of the study before agreeing to participate. Specifically, individuals who presented with abdominal pain, suspected to be associated with acute pancreatitis were admitted. This study was a prospective observational single-centre cohort study, which enabled the collection of data over a specific time frame, in this case spanned from March 2023 to December 2023. Patients suspected of having acute pancreatitis and those who met all the predetermined inclusion and exclusion criteria were extended an invitation to partake in the study and were subsequently enrolled after obtaining their consent. As part of the assessment process, the Harmless Acute Pancreatic (HAP) and Bedside Index for Severity in Acute Pancreatitis (BISAP) scores were administered to the patients, allowing for a comprehensive evaluation of their condition. With consideration of inclusion criteria, all patients who were at least 18 years old and carried a primary diagnosis of acute pancreatitis were deemed eligible for this study. Individuals were excluded from the study due to the presence of chronic pancreatitis, acute on chronic pancreatitis, post Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis or pregnancy, traumatic pancreatitis, or malignancy. In terms of the methodology employed, a convenience non-probability sampling method was utilized, thus ensuring that the selection of participants was based on accessibility and convenience rather than randomization.

Statistical Analysis

Categories are shown numerically, along with the associated percentages. The continuous variables were shown using their mean value, standard deviation, and median. A diagnostic test was performed to assess sensitivity, specificity, positive predictive value, along with negative predictive value. To evaluate the prediction capacities of HAPS and BISAP in terms of result, the receiver operating characteristic (ROC) curve was used. To quantify this comparison, the area under the curve for both variables was computed. All the information gathered throughout the study were methodically put into an MS EXCEL spreadsheet for further examination. In the following phases, the well renowned Statistical Package for Social Sciences (SPSS) version 21.0 was utilized for the study.

Results

The study population consisted of a total of 50 subjects, with the majority being males accounting for 40 patients (80%), while the remaining 10 patients (20%) were females. The age range of the patients varied significantly, spanning from 18 years to 80 years. The largest proportion of cases, amounting to 50%, were found in the age group of 21-40 years. Upon further analysis of the data, alcohol was identified as the associated risk factor in 56% of the patients, followed by gallstones in 24% of the patients. Interestingly, only a minimal percentage of patients (6%) presented with Systemic Inflammatory Response Syndrome (SIRS). Yet, it is important to highlight that all subjects in the study ultimately developed severe pancreatitis.

The investigation also explored the presence of peritonitis signs among the patient cohort. The findings revealed that 18 patients (36%) exhibited signs of peritonitis, while the remaining patients were devoid of such symptoms. Among the 18 patients with peritonitis signs, 30% developed severe pancreatitis. Furthermore, on analysis of serum creatinine levels in the patients, 16 individuals (32%) showcased elevated concentrations of this biomarker. Remarkably, an increased serum creatinine concentration within 24 hours of the episode yielded a strong association with the development of complications.

Moreover, the study examined the haematocrit values among the patients and found that 10% exhibited raised levels. Importantly, an escalation in haematocrits at the time of admission was correlated with an augmented risk of developing necrotizing acute pancreatitis. All patients in the study group underwent an abdominal ultrasound (USG), through which the presence of pancreatic necrosis was identified in four patients (8%), while five patients (10%) presented with a pseudocyst.

We conducted a comparison between the group of patients who tested negative for the HAPS and the group with low mortality as indicated by the Bedside Index for Severity in Acute Pancreatitis (BISAP) scoring system, which consists of scores ranging from 0 to 2 (Figure 1 and 2). Similarly, we compared the HAPS positive group with the BISAP high mortality group, which comprises scores ranging from 3 to 5. In a total of 27 patients who received a positive result for HAPS, a significant number of patients (10), equivalent to 37%, experienced a severe course during their stay at the hospital. Interestingly, out of the 23 patients who were found to be negative for HAPS, a notable proportion of nine patients, amounting to 13%, developed a severe form of acute pancreatitis. The sensitivity and specificity of the HAPS scoring system were determined to be 67% and 92.9%, respectively. Moreover, it is worth mentioning that in our study, in 36 patients, comprising approximately 76% of the total, a Bedside index severity score below 3 was observed, indicating a relatively better prognosis. However, in contrast, 14 patients, constituting around 28% of the total, exhibited a score of 3 or higher in Bedside index for severity in acute pancreatitis, thereby predicting a poorer prognosis. The sensitivity and specificity of the Bedside index severity scoring system were revealed to be 88% and 100%, respectively (Table 1)

Area under ROC curve was calculated for Bedside index severity score and Harmless acute pancreatic score for predicting the severity of acute pancreatitis. ROC curve HAP score was 0.8969 and BISAP score was 0.8925 (Figure 3). The Kappa value agreement between the two scores was 0.50. Thus, it was inferred that both the scores can be used for assessing the predication of acute pancreatitis. There was no significant difference between both scores (HAPS and BISAP) in envisaging the outcome of pancreatitis (Table 2).

Discussion

The Harmless Acute Pancreatitis Score (HAPS), can be rapidly considered based on three parameters, namely the absence of abdominal tenderness or rebound tenderness, creatinine and haematocrit levels.⁴ Lankisch PG in a recent study conducted at the Municipal Clinic of Luneburg, Germany, in the years 1987 and 2006, enrolled a total of 452 patients, and the correlation between HAPS and a non-severe course of the disease was observed to be statistically significant (P <.0001).⁵ The significance of the Harmless acute pancreatic score lies in its ability to find, within approximately thirty minutes after admitting the patients who are afflicted with acute pancreatitis, but are likely to experience a mild course of the disease. Furthermore, the evaluation showcases an exceedingly elevated degree of precision, reaching as high as 98%, that enables medical professionals to swiftly identify patients who do not require admission and intensive care treatment. Consequently, the implementation of the HAPS has the potential to yield substantial cost savings for hospitals. Another scoring system that plays a pivotal role in the prognostication of pancreatitis severity is the Bedside Index for Severity in Acute Pancreatitis, which is a straightforward scoring that is conducted upon admission. By promptly identifying patients who are at potential risk of developing severe pancreatitis or its complications, the BISAP allows for effective triaging of patients and the provision of appropriate treatment. This conception is supported by the findings of Sumitra Hagje who concluded that the Bedside index severity score exhibits strong predictive capabilities for severity, organ failure, and death in cases of acute pancreatitis.⁶ Actually, the Bedside index severity index score has been demonstrated to perform similarly to the APACHE-II scoring system, while surpassing other criteria such as the, Ct Severity Index score (CTSI), C reactive Protein (CRP), haematocrit, Ranson criteria and BMI. Moreover, it's noteworthy that the Procalcitonin (PCT) test has emerged as a promising inflammatory marker, displaying prediction rates akin to those of the BISAP scoring system. This implies that the PCT test, like the BISAP score, holds great potential in aiding the management and prognosis of acute pancreatitis. Overall, the utilization of these scoring systems and inflammatory markers in clinical settings enables early intervention and personalized care for patients suffering from acute pancreatitis.

The intention of this research was to assess the efficiency of the HAPS and BISAP scoring systems for the early forecast of the severity of pancreatitis at the time of admission. The acute pancreatitis has the potential to manifest in individuals across all age groups, although it is more commonly observed in middle-aged individuals. The most common clinical presentation of acute pancreatitis encompasses a range of symptoms, including abdominal pain, nausea, and vomiting. Alcohol consumption and the presence of gallstones are identified as the most frequent causes of acute pancreatitis. Within our study population, it was observed that alcoholic pancreatic inflammation accounted for 56% of the cases. The utilization of the BISAP and HAPS scoring systems can greatly assist in the triage of patients upon admission, thereby enabling the appropriate management setting to be determined within one hour of presentation. The existing prognostic scoring systems face several limitations and challenges, all of which are effectively addressed by the HAPS and BISAP scoring systems.

The BISAP scoring system encompasses five variables, namely BUN, mental status, SIRS, age, and pleural effusion.⁷ Previous studies conducted by Park have concluded that the BISAP scoring system is capable of predicting the severity, death rate, and organ failure in acute pancreatitis, similar to the APACHE-II scoring system. Furthermore, the BISAP scoring system surpasses the predictive capabilities of the Ranson criteria, CTSI, CRP, hematocrit, and BMI.⁸ A note-worthy finding from a study conducted by Lankisch et al., ⁹ is that the presence of pleural effusion serves as a negative prognostic parameter for severe acute pancreatitis. The Harmless acute pancreatic scoring system incorporates three variables, namely hematocrit, serum creatinine, and signs of peritonitis. In a retro-spective study conducted by Wan J et al., involving a total of 6024 patients from 2005 to 2016, the effectiveness of serum creatinine levels and APACHEII scores within 24 hours of admission was evaluated.¹⁰

The research findings indicated that a serum creatinine level exceeding 1.8 mg/dL within twenty-four hours of admission serves as a positive predictor of persistent organ failure in acute pancreatitis. Conversely, values below 1.8 mg/dL can be valuable for indicating the absence of organ failure in acute pancreatitis.

Additionally, Gardner et al., conducted a retrospective study at Dartmouth Hitchcock Medical Centre in Lebanon on 230 patients from 1990 to 2003 to evaluate the relationship between hemoconcentration and pancreatic necrosis.¹¹ The research revealed that a hematocrit level exceeding forty-four percentage upon admission or the absence of a decrease in hematocrit level within twenty-four hours after admission is associated with a heightened risk of developing necrotizing acute pancreatitis. Conversely, the absence of hemoconcentration has a higher negative predictive value for the development of severe acute pancreatitis. In fact, the absence of hemoconcentration at the time of admission or a drop in the hematocrit level within 24 hours reliably predicts that the patient will not develop necrosis. These findings highlight the critical role played by the HAPS and BISAP scoring systems in the early prediction of the severity of pancreatitis at the time of admission. By accurately assessing the variables within these scoring systems, healthcare professionals can make informed decisions regarding the appropriate management setting for patients, thereby optimizing patient outcomes and reducing the burden on healthcare resources. Overall, the HAPS and BISAP scoring systems represent significant advancements in the field of pancreatology and have the potential to revolutionize the early prediction and management of acute pancreatitis. The value that indicates the probability of a negative result was discovered to be 94.7% when the level of hematocrit exceeds 44%.

Overall, our study provides valuable insights into the demographic characteristics and associated risk factors among patients with pancreatitis. The analysis of various clinical parameters, including peritonitis signs, serum creatinine levels, haematocrit values, and ultrasound findings, contributes to a comprehensive understanding of the disease. These findings can aid healthcare professionals in the early detection, management, and prevention of complications associated with pancreatitis.

Limitations of study

This study was a single center study and involved only 50 patients. The results of our single arm study were not compared with similar groups.

Conclusion

The investigation underscored that both the scoring systems exhibited notable sensitivity and specificity in terms of forecasting the severity of acute pancreatitis, with the BISAP score revealing higher specificity in comparison to the HAPS score. It is apparent that both scoring systems possess their individual array of benefits and can assume a pivotal role in the initial categorization and are suitable for handling the patients afflicted with acute pancreatitis. The results of the study placed great emphasis on the fact that these scoring systems, which are relatively uncomplicated to compute and routinely carried out at the point of admission, can provide valuable insights into the identification of mild instances of acute pancreatitis.

Conflict of Interest

Nil