A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease Progression in Acute Pancreatitis

Cedars-Sinai Medical Center160 enrolled

Overview

The Purpose of this study is to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods.

There is no question that long-term heavy consumption of alcohol leads to increased risk of recurrent acute and chronic pancreatitis. While many patients and providers assume that heavy episodic alcohol consumption leads to acute pancreatitis, it is yet unknown whether 'binge' drinking truly causes pancreatitis and if so, what the relevant timing and duration of hazardous alcohol consumption is. Because of the lack of clarity on the transient effects of alcohol on acute pancreatitis, patients and providers are left with an uncertain disease progression and lack of tailored alcohol reduction recommendations. Our study aims to investigate changes in alcohol consumption in the period leading up to the onset of pancreatitis and compare that to levels of drinking during asymptomatic periods. This epidemiologic design is called the case-crossover study, in which the diseased person serves as his/her own control. This study design has advantages over typical case-control studies in that factors that do not change within the individual, such as sex, race, genetic risks, will not interfere with evaluating the causal role of heavy episodic drinking on pancreatitis. Participants in this study will undergo detailed interview on recent and lifetime alcohol consumption and other correlated health behaviors while they are hospitalized. Blood and urine will be collected during the hospitalization. After discharge, they will be interviewed again for any changes in alcohol consumption and blood and urine will be collected during a standard of care visit. The investigators will chart the progression of their disease through quarterly check-up by phone and through the medical records. Ultimately, the investigators aim to generate data that will empower patients and providers to develop tailored regimens for prevention of recurrent acute pancreatitis, that will have lasting beneficial effects in averting irreversible damage to the pancreas.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Pancreatitis, Acute Alcohol Drinking Health Behavior

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18-75 years at the time of eligibility assessment * Currently hospitalized with Acute Pancreatitis (AP) per Revised Atlanta Classification, which requires two of the following evidence of pancreatitis: 1. Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal 3. Characteristic findings of AP on computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography * Alcohol Use Disorders Identification Test Consumption (AUDIT-C) alcohol consumption score of ≥3 Exclusion Criteria: * Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors. * Chronic pancreatitis with calcification(s). * Pancreatic cancer or pancreatic metastasis from other malignancies. * History of pancreas transplant or pancreatectomy * Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures or participate in longitudinal follow up. * Currently incarcerated. * Known current pregnancy.

Locations (5)

University of Southern California

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Alcohol Consumption

Compare alcohol consumption prior to an attack of Acute Pancreatitis to that during an asymptomatic control period. Alcohol consumption will be measured by a 48-hour recall questionnaire, and timeline follow-back instrument.

Time frame: Between 5-26 weeks

Data from ClinicalTrials.gov

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