How long to wait before operating on the gall bladder after gallstone-induced acute pancreatitis?

Not Applicable

• Conditions: Mild biliary pancreatitis; Digestive System; Mild acute biliary pancreatitis

• Registration Number: ISRCTN10667869
• Lead Sponsor: niversity of Pécs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 10 December 2019
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 89

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Composite endpoint, which is based on mortality and on the following recurrent biliary events:<br> 1. Recurrent acute biliary pancreatitis (ABP)<br> 2. Acute cholecystitis<br> 3. Uncomplicated biliary colic<br> 4. Cholangitis<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> The following are assessed using questionnaires and evaluation of medical records 90 days after discharge:<br> 1. Number of biliary colics for each patient<br> 2. Difficult of cholecystectomy<br> 3. Rate of conversion to cholecystectomy<br> 4. Total length of hospital stay<br> 5. Need for ICU admission and total length of ICU stay<br> 6. Organ failure<br> 7. Biliary leakage<br>