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

Status unconfirmed

Conditions studied: Pancreatitis, Acute, Alcohol Drinking, Health Behavior

In brief

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.

Key facts

Study ID

NCT04743323

Run by

Cedars-Sinai Medical Center

People needed

160

Starts

2020-06-01

Expected to finish

2024-06-01

Last updated by the study team

2023-08-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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