Preventive pancreatic stents in the management of acute biliary pancreatitis

• Register: ISRCTN
• Last refreshed on: 18 May 2020
• Main ID: ISRCTN13517695
• Date of registration: 09/12/2014
• Prospective Registration: Yes
• Primary sponsor: Hungarian Pancreatic Study Group (HPSG) (Hungary)
• Public title: Preventive pancreatic stents in the management of acute biliary pancreatitis
• Scientific title: Preventive pancreatic stents in the management of acute biliary pancreatitis: PREPAST, a prospective multicenter randomized controlled trial (Hungarian Pancreatic Study Group)
• Date of first enrolment: 01/01/2015
• Target sample size: 230
• Recruitment status: Suspended
• URL: http://isrctn.com/ISRCTN13517695
• Study type: Interventional
• Study design: Prospective randomized controlled multicenter trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Hungary

Contacts

• Name: Zsolt Dubravcsik

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute biliary pancreatitis (ABP)
Digestive System
Biliary acute pancreatitis

Intervention(s)

Patients with ABP and co-existing acute cholangitis will recieve early endoscopic intervention (group A). Patients in group A will be randomized either into group A1 (ERCP, ES treatment) or into group A2 (ERCP, ES + PPS treatment). Patients with ABP but without evidence of acute cholangitis will be assessed for evidence of cholestasis. Patients without co-existing acute cholangitis but evidence of cholestasis will be randomized to receive conservative treatment or early ERCP, ES and bile duct clearance or early ERCP, ES, bile duct clearance plus PPS insertion (group B). Patients receiving conservative treatment will be assessed at 24 hours after randomization (no later than 72 hours from the onset of pain) for clinical and laboratory signs of persistent cholestasis. If this is present patients will recieve ERCP, ES and bile duct clearance and their data will be collected separately. Patients in group B will be randomized either into group B0 (conservative treatment), into group B1 (ERCP, ES treatment) or into group B2 (ERCP, ES + PPS treatment). Patients without signs of cholestasis (and acute cholangitis) will receive conservative treatment (group C), and will not be randomized.

Primary Outcome(s)

Composite of mortality and major morbidity (described as a complicated course of ABP). A complicated course is described as any of the following three:
1. Moderate and severe acute pancreatitis (including temporary and persistent organ failure)
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
3. Mortality

Secondary Outcome(s)

Secondary endpoints related to ABP outcome:
1. Multi-organ failure in each subgroup
2. Mortality rate in each subgroup
3. Pain score on admission, 24 and 72 hours after ERCP (or after randomization in group B1 ? conservative treatment group)
4. New onset of sepsis
5. The proportion of patients with severe course of ABP
6. The proportion of patients with severe organ failure requiring respiratory support (mechanical ventilation) and/or cardiac support (vasopressors) and/or renal support (haemodialysis)

Secondary endpoints related to endoscopic treatment:
1. PPS insertion success rate
2. Consequences of attempted but failed pancreatic stenting (this subgroup will be analyzed separately)
3. Endoscopist?s experience on PPS success rate and ABP outcome
4. The influence of the endoscopic technique used on the outcome of ABP
5. Influence of patient and procedure related risk factors of post-ERCP pancreatitis (published by the European Society of Gastrointestinal Endoscopy ? ESGE) on the outcome of ABP patients who underwent ERCP and on the success rate of PPS insertion

Secondary ID(s)

PREPAST

Source(s) of Monetary Support

Hungarian Pancreatic Study Group (HPSG) (Hungary), European Social Fund, European Union

Ethics review

Status:
Approval date:
Contact:

National Medical Ethics Committee, Hungary, 13/10/2014, ref.: ETT TUKEB 030174/2014/OTIG

Results

• Results available: Yes
• Date Completed: 31/08/2022