Investigating the effectiveness of early detection and treatment of bile duct stones in acute gallstone pancreatitis
Not Applicable
Completed
- Conditions
- Acute biliary pancreatitisDigestive System
- Registration Number
- ISRCTN15545919
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36849226/ (added 28/02/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
1. Acute biliary pancreatitis
2. Predicted severe disease course
3. EUS and ERC with sphincterotomy can be performed within 24 hours after admission
4. Aged 18 years or older
5. Written informed consent
6. In case of a previous episode of necrotizing pancreatitis, patient should be fully recovered
Exclusion Criteria
1. Cholangitis
2. Acute pancreatitis due to other causes such as alcohol abuse, metabolic causes, medication, trauma, etc.
3. Previous (precut) sphincterotomy
4. Chronic pancreatitis
5. International Normalised Ratio (INR) that cannot be corrected with co-fact or fresh frozen plasma below 1.5
6. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of severe morbidity and mortality occurring until 6 months after inclusion. Severe morbidity is defined as the occurrence of persistent single organ failure, necrotizing pancreatitis, bacteremia, cholangitis, pneumonia or exocrine or endocrine pancreatic insufficiency. After patient inclusion is completed and after the last patient has completed the 6 month follow-up, an adjudication committee consisting of 4 gastroenterologists, 2 surgeons and 1 radiologist will assess all potential endpoints (i.e. mortality and severe complications) and decide whether these concord with definitions of the primary endpoints. Using primary source data, each member of the committee will individually assess the potential endpoints. Disagreements will be resolved at a plenary consensus meeting.
- Secondary Outcome Measures
Name Time Method <br> The following are assessed at 6 month follow-up. For the secondary endpoints three sources of data are used: clinical record forms that are filled out by the treating physicians, primary source data and questionnaires filled out by the patients at 1,3 and 6 month follow-up.<br> 1. Individual components of the primary endpoint<br> 2. Length of hospital stay<br> 3. Need for of new intensive care admission<br> 4. Length of intensive care stay<br> 5. Respiratory complications<br> 6. Endoscopic retrograde cholangiography (ERC) related complications<br> 7. Number of endoscopic, radiological and operative (re-)interventions<br> 8. Readmission for biliary events<br> 9. Difficulty of cholecystectomy<br> 10. Economical evaluation<br>