Status:
UNKNOWN
A Case-CrossovEr Study deSign to Inform Tailored Interventions to Prevent Disease Progression in Acute Pancreatitis
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
United States Department of Defense
University of Pittsburgh
Conditions:
Pancreatitis, Acute
Alcohol Drinking
Eligibility:
All Genders
18-75 years
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 alcoh...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04743323
Start Date
June 1 2020
End Date
June 1 2024
Last Update
August 31 2023
Active Locations (5)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90034
3
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90034
4
Ohio State University
Columbus, Ohio, United States, 43210