Preventive pancreatic stents in the management of acute biliary pancreatitis
| ISRCTN | ISRCTN13517695 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13517695 |
| Secondary identifying numbers | PREPAST |
- 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
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
Scientific
Nyíri út 38
Kecskemet
6000
Hungary
| Phone | +36 (0) 30 9599257 |
|---|---|
| dubravcsikzs@gmail.com |
Scientific
University of Szeged
Dugonics Ter 13
Szeged
6720
Hungary
| Phone | +36 (0)70 3751031 |
|---|---|
| hegyi2009@gmail.com |
Study information
| Study design | Prospective randomized controlled multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2015 |
| Completion date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Dugonics Ter 13
Szeged
6720
Hungary
Nyiri ut 38.
Kecskemet
6000
Hungary
Ifjusag ut 13.
Pecs
7624
Hungary
Podmaniczky u. 111.
Budapest
1062
Hungary
Sponsor information
Research organisation
Korányi fasor 8-10
Szeged
6720
Hungary
| Website | http://www.pancreas.hu |
|---|
Funders
Funder type
Research organisation
No information available
Government organisation / National government
- Alternative name(s)
- Европейският социален фонд, Evropský sociální fond, Den Europæiske Socialfond, Europäischer Sozialfonds, Euroopa Sotsiaalfond, Ευρωπαϊκό Κοινωνικό Ταμείο, Fondo Social Europeo, Fonds social européen, Europski socijalni fond, Fondo sociale europeO, Eiropas Sociālais fonds, Europos socialinis fondas, Európai Szociális Alap, Fond Soċjali Ewropew, Europees Sociaal FondS, Europejski Fundusz Społeczny, Fundo Social Europeu, Fondul Social European, Európsky sociálny fond, Evropski socialni sklad, Euroopan sosiaalirahasto, Europeiska socialfonden, European Social Fund, Fondo Social Europeo Plus, Европейски социален фонд плюс, Evropský sociální fond plus, Europæiske Socialfond Plus, Europäische Sozialfonds+, Euroopa Sotsiaalfond+, Ευρωπαϊκό Κοινωνικό Ταμείο+, Fonds social européen+, Europski socijalni fond plus, Fondo sociale europeo Plus, Eiropas Sociālais fonds Plus, Europos socialinis fondas +, Európai Szociális Alap Plusz, Europees Sociaal Fonds Plus, Europejski Fundusz Społeczny Plus, Fundo Social Europeu Mais, Fondul social european Plus, Európsky sociálny fond +, Evropski socialni sklad +, Euroopan sosiaalirahasto plus, Europeiska socialfonden+, ESF, ЕСФ, EKT, FSE, ESZA, EFS, ESS, ESR, ESF+, ESZA+, EFS+, FSE+, ESS+, ESR+
No information available
Results and Publications
| Intention to publish date | 31/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2015 | Yes | No |
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.
