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

NCT04743323 | Unknown

• 2 other identifiers: STUDY000003647W81XWH1910888
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 5

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.

Conditions

Pancreatitis, Acute; Alcohol Drinking; Health Behavior

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults that consume alcohol who are hospitalized for acute pancreatitis.

You may qualify if:

• 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:
• Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
• Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• United States Department of Defense: collaborator
• University of Pittsburgh: collaborator
• Alcohol Research Group: collaborator
• Ohio State University: collaborator
• VA Greater Los Angeles Healthcare System: collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90034, United States

Location

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90034, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburg

Pittsburgh, Pennsylvania, 15260, United States

Location

Related 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.

  PMID: 17286349 BACKGROUND

• 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.

  PMID: 34229971 BACKGROUND

• 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.

  PMID: 37567847 RESULT

MeSH Terms

Conditions

Pancreatitis; Alcohol Drinking; Health Behavior

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Drinking Behavior; Behavior

Study Officials

• Christie Y Jeon, ScD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 8, 2021
• Study Start: June 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)