Plain English Summary
Background and study aims
Acute inflammation of the pancreas (acute pancreatitis) can be a severe or even life-threatening disease. Gallstones are the most common cause, which is called acute biliary pancreatitis (ABP). If you have co-existing infection and inflammation of the biliary tree (acute cholangitis) and/or persistent biliary obstruction (cholestasis), an endoscopic procedure (called ERCP) is beneficial which includes clearance of the biliary tree. Severe complications occur in 10-20% of all cases despite endoscopic treatment, probably because the opening of the pancreatic duct is simultaneously obstructed. Theoretically when we temporarily place a small plastic tube (a preventive pancreatic stent or PPS) into the pancreatic duct, it keeps it open until the inflammation resolves and the risk of pancreatic duct obstruction diminishes. Our goal is to show the positive effect of PPS placement added to the standard endoscopic therapy. The study findings should help to optimize the treatment of this severe disease.
Who can participate?
Patients aged 18 or over with cholangitis and/or cholestasis.
What does the study involve?
Participants will be randomly allocated to receive either the standard endoscopic treatment or PPS placement added to the standard treatment. Every patient will be hospitalized and receive similar medical treatment. Clinical and laboratory data will be collected for outcome measures.
What are the possible benefits and risks of participating?
Patients who receive PPSs may have better overall outcome and quicker symptom resolution compared to the standard treatment. The main risk of placing a PPS is unsuccessful placement which might cause an even worse outcome; therefore only very experienced endoscopists are involved in this study.
Where is the study run from?
The PREPAST study is set up by the Hungarian Pancreatic Study Group in Szeged, Hungary. All procedures will be performed at the participating medical centers.
When is the study starting and how long is expected to run for?
It is anticipated that recruitment will start in early 2015. Based on our preliminary calculations the total target number of participants will be enrolled over a 4-year period; however, if more centers join in the study it will be shorter.
Who is funding the study?
The Hungarian Pancreatic Study Group (HPSG).
Who is the main contact?
Zsolt Dubravcsik MD
dubravcsikzs@gmail.com
Professor Péter Hegyi MD, PhD,
hegyi2009@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Zsolt Dubravcsik
ORCID ID
Contact details
Nyíri út 38
Kecskemet
6000
Hungary
+36 (0) 30 9599257
dubravcsikzs@gmail.com
Type
Scientific
Additional contact
Dr Peter Hegyi
ORCID ID
Contact details
University of Szeged
Dugonics Ter 13
Szeged
6720
Hungary
+36 (0)70 3751031
hegyi2009@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PREPAST
Study information
Scientific title
Preventive pancreatic stents in the management of acute biliary pancreatitis: PREPAST, a prospective multicenter randomized controlled trial (Hungarian Pancreatic Study Group)
Acronym
PREPAST
Study hypothesis
We hypothesise that placement of a preventive pancreatic stent (PPS) at the course of early endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (ES) and stone extraction reduces morbidity and mortality in acute biliary pancreatitis (ABP) patients with cholangitis and/or cholestasis compared to the standard of care ERCP, ES and stone extraction.
Ethics approval
National Medical Ethics Committee, Hungary, 13/10/2014, ref.: ETT TUKEB 030174/2014/OTIG
Study design
Prospective randomized controlled multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute biliary pancreatitis (ABP)
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 measures
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. Endoscopists 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
Overall trial start date
01/01/2015
Overall trial end date
01/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
230
Participant 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
Recruitment start date
01/01/2015
Recruitment end date
01/12/2018
Locations
Countries of recruitment
Hungary
Trial participating centre
University of Szeged
1st Department of Internal Medicine
Dugonics Ter 13
Szeged
6720
Hungary
Trial participating centre
County Hospital
Department of Gatsroenterology
Nyiri ut 38.
Kecskemet
6000
Hungary
Trial participating centre
University of Pecs
1st. Department of Internal Medicine
Ifjusag ut 13.
Pecs
7624
Hungary
Trial participating centre
National Health Center
Department of Gastroenterology
Podmaniczky u. 111.
Budapest
1062
Hungary
Sponsor information
Organisation
Hungarian Pancreatic Study Group (HPSG) (Hungary)
Sponsor details
Korányi fasor 8-10
Szeged
6720
Hungary
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Hungarian Pancreatic Study Group (HPSG) (Hungary)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Social Fund
Alternative name(s)
Fondo Social Europeo, Fonds Social Européen, Europäische Sozialfonds, ESF
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Funder name
European Union
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We would like to publish our trial protocol once the registration has been confirmed (the trial article has been prepared). We would like to publish our results at the end of the trial.
Intention to publish date
Participant level data
Other
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25754525