Mild biliary pancreatitis Digestive System Mild acute biliary pancreatitis
Conditions
Interventions
Participants will be randomised by the study coordinator using a randomisation module with sealed envelope. This randomisation module will allocate the participants to the 2 different groups. Allocati
Sponsors
University of Pécs
Hungarian Academy of Sciences, Momentum Grant
GINOP 2.3.2.-15 'Stay Alive'
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Diagnosis of acute pancreatitis, with at least 2 of the following symptoms: 2.1. Upper abdominal pain 2.2. Serum lipase three times higher than the upper limit of normal and characteristic findings for acute pancreatitis on imaging 2.3. Serum amylase three times higher than the upper limit of normal and characteristic findings for acute pancreatitis on imaging 3. Mild biliary pancreatitis (no pancreatic necrosis, no transient or persistent organ failure (>48 hours)) according to the revised Atlanta classification 4. Any of the following 3 definitions of biliary pancreatitis: 4.1. Diagnosis of gallstones or sludge on imaging 4.2. Dilated common bile duct on ultrasound (>8 mm in patients aged 75 years old and under, or >10 mm in patients over 75 years old) with the absence of gallstones or sludge in the gallbladder 4.3. Alanine aminotransferase level >2 times higher than normal values, with alanine aminotransferase levels greater than aspartate aminotransferase levels 5. ERCP/ES either during the index admission or in the medical history without complication (added 01/02/2019) 6. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Poor physical status 2. American Society of Anesthesiologists (ASA) class III in patients over 75 years old 3. ASA class IV or V in patients 75 years old or younger 4. Continuous alcohol abuse 5. Chronic pancreatitis 6. Pregnancy 7. Previous sphincterotomy (removed 01/02/2019) 8. Previous cholecystectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint, which is based on mortality and on the following recurrent biliary events: 1. Recurrent acute biliary pancreatitis (ABP) 2. Acute cholecystitis 3. Uncomplicated biliary colic 4. Cholangitis This will be evaluated using yes/no questions as part of a questionnaire up to 90 days after discharge. Patients will be asked to note every biliary event using questionnaires during the 3 month follow-up observational period following discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed using questionnaires and evaluation of medical records 90 days after discharge: 1. Number of biliary colics for each patient 2. Difficult of cholecystectomy 3. Rate of conversion to cholecystectomy 4. Total length of hospital stay 5. Need for ICU admission and total length of ICU stay 6. Organ failure 7. Biliary leakage | — |
Countries
Hungary, Romania
Outcome results
None listed