Clinical trial NCT04743323: A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease Progression in Acute Pancreatitis
Official title: A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatitis, Acute
Alcohol Drinking
Health Behavior
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Pittsburgh
name: Alcohol Research Group
name: Ohio State University
name: VA Greater Los Angeles Healthcare System
First posted: 2021-02-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults that consume alcohol who are hospitalized for acute pancreatitis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alcohol Consumption
timeFrame: Between 5-26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Veterans Affairs Greater Los Angeles Healthcare System
state: California
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburg
state: Pennsylvania
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Christie Y Jeon, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cherpitel CJ, Ye Y, Bond J, Borges G, Macdonald S, Stockwell T, Room R, Sovinova H, Marais S, Giesbrecht N. Validity of self-reported drinking before injury compared with a physiological measure: cross-national analysis of emergency-department data from 16 countries. J Stud Alcohol Drugs. 2007 Mar;68(2):296-302. doi: 10.15288/jsad.2007.68.296.
citation: Jeon CY, Papachristou GI, Pisegna JR, Pendergast FJ, Lin YC, Cherpitel CJ, Ye Y, Pandol SJ, Yadav D. A Case-CrossovEr study deSign to inform tailored interventions to prevent disease progression in Acute Pancreatitis (ACCESS-AP) - study design and population. Pancreatology. 2021 Oct;21(7):1231-1236. doi: 10.1016/j.pan.2021.06.007. Epub 2021 Jun 24.
citation: Jeon CY, Adeniran E, Stewart C, Papachristou GI, Pisegna JR, Kuc AA, Buxbaum JL, Pandol SJ, Yadav D. Female patients delay seeking medical care with alcohol-associated acute pancreatitis. Pancreatology. 2023 Nov;23(7):761-766. doi: 10.1016/j.pan.2023.08.001. Epub 2023 Aug 5.