Status:
UNKNOWN
Continuous Alcohol Monitoring for Pancreatitis
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Pancreatitis
Alcohol Drinking
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transd...
Detailed Description
Alcohol is the leading cause of recurrent acute and chronic pancreatitis, which greatly elevates the risk of pancreatic cancer. Reducing alcohol intake in patients with a history of alcoholic pancreat...
Eligibility Criteria
Inclusion
- Aged 18-75 years at the time of eligibility assessment
- History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, 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 contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
- Access to a mobile or portable device that has the capability to sync to the BACtrack sensor and internet connection for syncing purposes.
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.
- Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.
- Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures.
- Currently incarcerated.
- Known pregnancy.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04350996
Start Date
June 1 2020
End Date
June 1 2021
Last Update
April 29 2020
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048