Condition category
Digestive System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

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
Professor Péter Hegyi MD, PhD,

Trial website

Contact information



Primary contact

Dr Zsolt Dubravcsik


Contact details

Nyíri út 38
+36 (0) 30 9599257



Additional contact

Dr Peter Hegyi


Contact details

University of Szeged
Dugonics Ter 13
+36 (0)70 3751031

Additional identifiers

EudraCT number number

Protocol/serial number


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)



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Acute biliary pancreatitis (ABP)


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



Drug names

Primary outcome measures

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. 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

Overall trial start date


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

University of Szeged
1st Department of Internal Medicine Dugonics Ter 13

Trial participating centre

County Hospital
Department of Gatsroenterology Nyiri ut 38.

Trial participating centre

University of Pecs
1st. Department of Internal Medicine Ifjusag ut 13.

Trial participating centre

National Health Center
Department of Gastroenterology Podmaniczky u. 111.

Sponsor information


Hungarian Pancreatic Study Group (HPSG) (Hungary)

Sponsor details

Korányi fasor 8-10

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Hungarian Pancreatic Study Group (HPSG) (Hungary)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

European Social Fund

Alternative name(s)

Fondo Social Europeo, Europäische Sozialfonds, Fonds Social Européen, ESF

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



Funder name

European Union

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Results - basic reporting

Publication summary

2015 protocol in:

Publication citations

Additional files

Editorial Notes