Preventive pancreatic stents in the management of acute biliary pancreatitis

Not Applicable

Suspended

• Conditions: Acute biliary pancreatitis (ABP); Digestive System; Biliary acute pancreatitis

• Registration Number: ISRCTN13517695
• Lead Sponsor: Hungarian Pancreatic Study Group (HPSG) (Hungary)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25754525

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-09
• Last Update Posted: 18 May 2020
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Age = 18 years (either sex)
2. Diagnosis of acute biliary pancreatitis
3. Written informed consent
4. Possibility of performing ERCP within 48 hours calculated from the onset of pain

Exclusion Criteria

1. Pregnancy
2. Acute pancreatitis due to alcohol, hyperlipidaemia, malignancy or post-ERCP pancreatitis
3. Pain onset >48 hours
4. Abscence of abdominal pain (the onset cannot be assessed)
5. Liver cirrhosis Child score C
6. Pancreatic fluid collections or necrosis on initial imaging at presentation
7. INR>1.6 and uncorrectable by the time of ERCP
8. Previous endoscopic sphincterotomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Composite of mortality and major morbidity (described as a complicated course of ABP). A complicated course is described as any of the following three:<br> 1. Moderate and severe acute pancreatitis (including temporary and persistent organ failure)<br> 2. Any complications including systemic (exacerbation of pre-existing co-morbidity) and all local complications (acute peripancreatic fluid collection without tendency of spontaneous resolution, pancreatic pseudocyst, acute necrotic collection, walled-off necrosis) of AP as described in the revised Atlanta classification<br> 3. Mortality<br>