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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Drinking; Health Behavior; Pancreatitis, Acute

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90034
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90034
      • Veterans Affairs Greater Los Angeles Healthcare System
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults that consume alcohol who are hospitalized for acute pancreatitis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Study Participants; Participants will be recruited whilst hospitalized for an acute episode of pancreatitis. They will be interviewed about their health behaviors including alcohol consumption during the two weeks immediately preceding the onset of pancreatitis. Blood and urine bio-specimens will be collected at this time. Following discharge from hospital (5-26 weeks) the same participant will be interviewed again during an asymptomatic control period and blood and urine bio-specimens will be collected. This study will compare the participant's exposure immediately preceding the onset of pancreatitis to that of an asymptomatic control period from the same participant. Participants will be followed for 24 months via review of their medical records every 6 months to assess any recurrent disease or progression of disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between 5-26 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: United States Department of Defense; University of Pittsburgh; Ohio State University; VA Greater Los Angeles Healthcare System; Alcohol Research Group
• Investigators: Principal Investigator: Christie Y Jeon, ScD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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 Aug 5:S1424-3903(23)01605-8. doi: 10.1016/j.pan.2023.08.001. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Drinking Behavior; Pancreatic Diseases; Alcohol Drinking; Pancreatitis
• Other Study ID Numbers: STUDY00000364; 7W81XWH1910888 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No