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

A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04743323
Acronym
ACCESS-AP
Enrollment
160
Registered
2021-02-08
Start date
2020-06-01
Completion date
2024-06-01
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Health Behavior, Pancreatitis, Acute

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.

Interventions

None listed

Sponsors

United States Department of Defense
CollaboratorFED
University of Pittsburgh
CollaboratorOTHER
Alcohol Research Group
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
VA Greater Los Angeles Healthcare System
CollaboratorFED
Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Alcohol ConsumptionBetween 5-26 weeksCompare 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026