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

Health Behavior Clinical Trial

— ACCESS-AP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04743323
• Other study ID #: STUDY00000364
• Secondary ID: 7W81XWH1910888
• Status: Active, not recruiting
• Start date: June 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Health Behavior
• Pancreatitis
• Pancreatitis, Acute

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Veterans Affairs Greater Los Angeles Healthcare System	Los Angeles	California
United States	University of Pittsburg	Pittsburgh	Pennsylvania

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 Aug 5:S1424-3903(23)01605-8. doi: 10.1016/j.pan — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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