Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial)
| ISRCTN | ISRCTN97372133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97372133 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/11/2012
- Registration date
- 17/12/2012
- Last edited
- 21/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Acute biliary pancreatitis is inflammation of the pancreas caused by obstruction of the pancreatic duct. Relieving the obstruction early with an operation called endoscopic retrograde cholangiography (ERC) plus endoscopic sphincterotomy (ES) may be beneficial. The aim of this study is to investigate whether early ERC plus ES reduces complications and/or the number of deaths in patients with acute biliary pancreatitis.
Who can participate?
Patients aged over 18 with acute biliary pancreatitis.
What does the study involve?
Participants are randomly allocated to one of two groups. One group undergoes early ERC plus ES (i.e., within 24 hours of admission to hospital). The other group receives conservative treatment and delayed ERC is performed when clinically indicated.
What are the possible benefits and risks of participating?
Patients in the early ERC/ES group may benefit from early clearance of the obstruction. This procedure may also lead to complications in a minority of patients. Patients in the conservative treatment group may be disadvantaged by reduced biliary drainage. The study design has several safety procedures and evaluation moments to guarantee the patients’ safety throughout the study.
Where is the study run from?
25 participating centers in the Netherlands.
When is the study starting and how long is it expected to run for?
March 2013 to April 2016.
Who is funding the study?
Fonds NutsOhra and Erasmus Medical Center, Rotterdam, the Netherlands.
Who is the main contact?
Prof. M.J. Bruno
m.bruno@erasmusmc.nl
Contact information
Scientific
Erasmus Medical Center
Department of Gastroenterology and Hepatology
s-Gravendijkwal 230
Rotterdam
3015CE
Netherlands
| Phone | +31 (0)10 703 5946 |
|---|---|
| m.bruno@erasmusmc.nl |
Study information
| Study design | Randomized superiority assessor-blinded multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at http://www.pancreatitis.nl/ |
| Scientific title | Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial): a randomized, superiority, assessor-blinded multicenter trial |
| Study acronym | APEC |
| Study hypothesis | We hypothesize that early endoscopic retrograde cholangiography (ERC) plus sphincterotomy improves the outcome of patients with acute biliary pancreatitis without cholangitis in whom the disease course is predicted to be severe. |
| Ethics approval(s) | Erasmus Medical Center Rotterdam Ethics Committee, 08/11/2012 ref: MEC-2012-357 |
| Condition | Acute biliary pancreatitis |
| Intervention | The trial will be performed by the Dutch Pancreatitis Study Group. A total of 232 patients will be randomized in 25 participating centers of the Dutch Pancreatitis Study Group. 1. Intervention group: early (<24 hours of admission) ERC plus sphincterotomy. 2. Comparison group: conservative (expectative) management, delayed ERC when clinically indicated. The total duration of follow-up is until 6 months after randomization. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | A composite of severe morbidity and mortality occurring until 6 months after randomization. Severe morbidity is defined as the occurrence of persistent single organ failure, necrotizing pancreatitis, bacteremia, cholangitis, pneumonia or exocrine or endocrine pancreatic insufficiency. |
| Secondary outcome measures | 1. Individual components of the primary endpoint 2. Length of hospital stay 3. Need for of new intensive care admission 4. Length of intensive care stay 5. Respiratory complications 6. ERC related complications 7. Number of endoscopic, radiological and operative (re-)interventions 8. Readmission for biliary events 9. Difficulty of cholecystectomy 10. Economical evaluation |
| Overall study start date | 01/12/2012 |
| Overall study end date | 31/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 232 patients |
| Total final enrolment | 232 |
| Participant inclusion criteria | 1. Acute biliary pancreatitis 2. Predicted severe disease course 3. ERC with sphincterotomy can be performed within 24 hours after admission 4. Age > 18 years 5. Written informed consent 6. In case of a previous episode of necrotizing pancreatitis, patient should be fully recovered |
| Participant exclusion criteria | 1. Cholangitis 2. Acute pancreatitis due to other causes such as alcohol abuse, metabolic causes, medication, trauma, etc. 3. Previous (precut) sphincterotomy 4. Chronic pancreatitis 5. INR that cannot be corrected with co-fact or fresh frozen plasma below 1.5 6. Pregnancy |
| Recruitment start date | 01/03/2013 |
| Recruitment end date | 30/04/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3015CE
Netherlands
Sponsor information
Hospital/treatment centre
Dutch Pancreatitis Study Group
Department of Gastroenterology and Hepatology
s-Gravendijkwal 230
Rotterdam
3015CE
Netherlands
| Phone | +31 (0)61 441 1960 |
|---|---|
| m.bruno@erasmusmc.nl | |
| Website | http://www.erasmusmc.nl |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- NutsOhra Foundation, NutsOhra Fund, Stichting Nuts Ohra
- Location
- Netherlands
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/01/2016 | Yes | No | |
| Results article | results | 18/07/2020 | 21/07/2020 | Yes | No |
Editorial Notes
21/07/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
