Clinical trial NCT04214756: Methodist Acute Pancreatitis Protocol
Official title: Methodist Acute Pancreatitis Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Pancreatitis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with acute pancreatitis beginning August 2011 at MDMC, MCMC, MMMC, and MRMC will be included in the registry for analysis of baseline and clinical outcomes data and subsequently divided into two groups (i.e. those treated pre-MAPP and post-MAPP).

Brief summary: The overall goal of this ongoing registry study is to optimize initial evaluation and treatment of patients with AP according to recommended guidelines, the Methodist Acute Pancreatitis Protocol (MAPP), which were implemented in January 2015.

Detailed description: 1.1. Background

Acute pancreatitis (AP) represents a significant burden for patients, their caregivers, and our healthcare delivery systems. The most common discharge gastrointestinal diagnosis is AP and more than two billion dollars is spent annually for management thereof . Costs are certainly even higher as the incidence of AP has increased. Admit frequency for AP doubled in 15 years before 2002 such that more than 200,000 admissions were attributed to AP, and the trend toward increased admissions for AP has continued. Overall, about 20% of AP cases are severe and the risk for fatality attributed to severe AP is significant (\> 25%). Classification of AP severity is defined into three groups: mild, moderately severe, and severe. These categories have been validated in that standard clinical outcomes correlate well with the severity of AP.

There are several principle gaps in knowledge with respect to AP. First, it remains challenging to initially predict the ultimate severity of acute pancreatitis . Some patients presenting with what is thought to be a mild attack of AP ultimately progress to having more severe disease. This is of utmost importance because outcomes of AP seem to be clearly related to very early diagnosis and appropriate initial management. For example, both morbidity and mortality for AP are closely related to persistent organ failure, which in theory might be prevented with very early appropriate management. It is also not clear if the existing data regarding prognostic scoring systems were influenced by early interventions. Secondly, we lack confirmatory data that following recommended guidelines for management of AP in fact results in improved clinical outcomes. It has been suggested that the care of AP patients has changed considerably during the last decade. One might assume that this change was in response to following one or all of several different guidelines produced by international societies. However, there is a paucity of outcomes data, particularly related to patients that have been cared for according to the recommended guidelines, and further investigation is warranted. Lastly, many AP studies include patients who had onset of symptoms more than several days prior to admission or transfer to a tertiary center; careful study is warranted in AP patients who present within one to two days of symptom onset.

The evaluation and treatment of all patients with AP according to specific guidelines embodies the principles of patient-centeredness research and improved clinical outcomes may also translate into better quality of life. Patients who suffer from severe AP that is complicated by pancreatic necrosis continue to have poor physical components of quality of life. However, the burden for patients with AP extends beyond the obvious clinical outcomes. Even as symptom scales from quality of life instruments improve following recovery, mental component scores remain significantly impaired.

1.2. AIMS/OBJECTIVES

Specific aims:

Aim 1: Compare the outcome of AP between the two groups. The total length of hospital stay (including ward stay and ICU stay) and the Discharge status (discharged or died) will be considered as the outcome of AP.

Aim 2: Compare the imaging study and hospital resource utilization (charges) between the two groups

Aim 3: Determine if the existing prognostic scoring systems are valid in this patient population when managed according the recommended guidelines.

1.3. HYPOTHESIS 1.4.1. Primary Hypothesis: The total length of hospital stay will be shorter for the group of patients treated after January 2015 (post-MAPP) than those treated before December 2014 (pre-MAPP). Additionally, more patients treated according to the guidelines will be discharged home (and not die in the hospital) as compared to the patients not treated according to the guidelines.

1.4.2. Secondary Hypothesis: There will be less utilization of imaging studies for patients treated according to the guidelines.

2.1. STUDY OBJECTIVES 2.1.1. Primary Objective Compare the total length of hospital stay (including ward stay and ICU stay) and the discharge status (discharged or died) between the pre- and post-MAPP AP patients.

2.1.2. Secondary Objectives

* Compare the imaging study and hospital resource utilization (charges) between the pre- and post-MAPP AP patients.
* Determine if the existing prognostic scoring systems are valid in the AP patient population when managed according the recommended guidelines

  3. STUDY DESIGN The proposed ongoing registry study will follow the cohort study design where baseline patient data and clinical outcomes data will be collected retrospectively. The registry will collect data on all AP patients since August 2011, and will continue until a sufficient number of cases are obtained to reach statistical significance. Retrospective data will be collected on patients diagnosed with AP based on two groups (those treated pre-MAPP and post-MAPP). Initial clinical criteria will be evaluated for the predictive value of AP severity in both groups.

  4. STUDY SETTING/LOCATION The study will be conducted with data from Methodist Dallas Medical Center (MDMC), Methodist Charlton Medical Center (MCMC), Methodist Mansfield Medical Center (MMMC) and Methodist Richardson Medical Center (MRMC).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Presented to ER with Acute severe pain for \< 48 hours before presentation.
* Laboratory values of Lipase and/or amylase \> 3X normal

Exclusion Criteria:

* History of recent penetrating or blunt abdominal trauma
* Patients transferred to MDMC for upper abdominal pain consistent with pancreatic etiology

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: Ward days
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: ICU days
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: Discharge status
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
Secondary outcomes:
measure: CT scan
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: Empiric antibiotics
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: Harmless AP score (HAPS)
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: bedside index for severity in AP (BISAP)
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: C reactive protein
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: Procalcitonin
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: organ dysfunction scores
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
measure: Severity of acute pancreatitis (AP)
timeFrame: From April 2016 until Jun 2025 (anticipated study close)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Paul Tarnasky, MD
role: PRINCIPAL_INVESTIGATOR
References: