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

Active, not recruiting

• Conditions: Health Behavior; Pancreatitis, Acute; Alcohol Drinking

• Registration Number: NCT04743323
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alcohol Consumption	Between 5-26 weeks	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.

Trial Locations

Locations (5)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pittsburg; 🇺🇸 Pittsburgh, Pennsylvania, United States

Veterans Affairs Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States