Preventive pancreatic stents in the management of acute biliary pancreatitis

ISRCTN	ISRCTN13517695
DOI	https://doi.org/10.1186/ISRCTN13517695
Protocol serial number	PREPAST
Sponsor	Hungarian Pancreatic Study Group (HPSG) (Hungary)
Funders	Hungarian Pancreatic Study Group (HPSG) (Hungary), European Social Fund, European Union

Submission date: 13/11/2014
Registration date: 09/12/2014
Last edited: 04/05/2020

Recruitment status: Suspended
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Zsolt Dubravcsik
Scientific

Nyíri út 38
Kecskemet
6000
Hungary

Phone	+36 (0) 30 9599257
Email	dubravcsikzs@gmail.com

Dr Peter Hegyi
Scientific

University of Szeged
Dugonics Ter 13
Szeged
6720
Hungary

Phone	+36 (0)70 3751031
Email	hegyi2009@gmail.com

Study information

Primary study design	Interventional
Study design	Prospective randomized controlled multicenter trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Preventive pancreatic stents in the management of acute biliary pancreatitis: PREPAST, a prospective multicenter randomized controlled trial (Hungarian Pancreatic Study Group)
Study acronym	PREPAST
Study objectives	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(s)	National Medical Ethics Committee, Hungary, 13/10/2014, ref.: ETT TUKEB 030174/2014/OTIG
Health condition(s) or problem(s) studied	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
Primary outcome measure(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
Key secondary outcome measure(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. 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
Completion date	31/08/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	230
Key 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
Key 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
Date of first enrolment	01/01/2015
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

Hungary

Study participating centres

University of Szeged

1st Department of Internal Medicine
Dugonics Ter 13
Szeged
6720
Hungary

County Hospital

Department of Gatsroenterology
Nyiri ut 38.
Kecskemet
6000
Hungary

University of Pecs

1st. Department of Internal Medicine
Ifjusag ut 13.
Pecs
7624
Hungary

National Health Center

Department of Gastroenterology
Podmaniczky u. 111.
Budapest
1062
Hungary

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/03/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
15/01/2019: The following changes have been made:
1. The intention to publish date has been added.
2. The recruitment end date has been changed from 01/12/2018 to 31/12/2021.
3. The overall trial end date has been changed from 01/12/2018 to 31/08/2022.