Preventive pancreatic stents in the management of acute biliary pancreatitis

Conditions

Acute biliary pancreatitis (ABP) Digestive System Biliary acute pancreatitis

Zsolt Dubravcsik, L Madácsy, T Gyökeres, Áron Vincze, Zoltán Szepes et al. (8 authors)

Zeitschrift für Gastroenterologie2015-05-12

Preventive pancreatic stents in the management of acute biliary pancreatitis (PREPAST trial): pre-study protocol for a multicenter, prospective, randomized, interventional, controlled trial.

Dubravcsik Z, Madácsy L, Gyökeres T, Vincze Á, Szepes Z, Hegyi P, Hritz I, Szepes A, Hungarian Pancreatic Study Group.

2015-02-2514 citations

10.1016/j.pan.2015.02.007

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Hungary

Outcome results

None listed