Investigating the effectiveness of early detection and treatment of bile duct stones in acute gallstone pancreatitis
| ISRCTN | ISRCTN15545919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15545919 |
| Secondary identifying numbers | MEC-2012-357 |
- Submission date
- 28/08/2018
- Registration date
- 10/09/2018
- Last edited
- 28/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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) with endoscopic sphincterotomy (ES) may be beneficial, especially if this condition is persistent. The aim of this study is to investigate whether early detection of common bile duct obstruction followed by direct treatment of such an obstruction with ERC plus ES, reduces complications and/or the number of deaths in patients with acute biliary pancreatitis.
Who can participate?
Adult patients with acute biliary pancreatitis
What does the study involve?
Participants are treated with early EUS (endoscopic ultrasound) (within 24 hours of admission to hospital) followed by direct ERC plus ES, if they have sludge and/or gallstones in their common bile duct.
What are the possible benefits and risks of participating?
Patients with sludge and/or gallstones in the common bile duct may benefit from undergoing ERC plus ES, as early clearance of the obstruction can be beneficial. In patients without biliary obstruction, unnecessary ERC plus ES can be prevented. The potential risk of participating is that the ERC plus ES procedure may lead to complications in a minority of patients; however, there are several safety procedures and evaluation moments to guarantee the patients’ safety throughout the study. These complications include bleeding, bowel perforation, cholangitis and aspiration pneumonia; however, these complications occur in around 1% of cases.
Where is the study run from?
Erasmus Medical Center (The Netherlands) and 18 participating centres in the Netherlands
When is the study starting and how long is it expected to run for?
June 2017 to September 2019
Who is funding the study?
Erasmus Medical Center (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
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
Study information
| Study design | Interventional prospective multi-centre non-randomised cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at https://pancreatitis.nl/studies/apec |
| Scientific title | EUS-guided early ERC with sphincterotomy in predicted severe biliary pancreatitis: a prospective, multicenter cohort study with a historic comparison |
| Study acronym | APEC-2 |
| Study objectives | We hypothesise that endoscopic ultrasonography (EUS)-guided early endoscopic retrograde cholangiography (ERC) with 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, 27/06/2017 ref: MEC-2012-357 |
| Health condition(s) or problem(s) studied | Acute biliary pancreatitis |
| Intervention | The study will be performed by the Dutch Pancreatitis Study Group. A total of 78 evaluable patients will be included in 18 participating centers. This group will receive early (<24 hours of admission) endoscopic ultrasound, followed by direct endoscopic retrograde cholangiography (ERC) with sphincterotomy if they have sludge or gallstones in the common bile duct. This will be compared with a historic cohort (the superior group of the APEC trial (ISRCTN97372133)). If the APEC trial shows no difference between the two groups, the conservative group or the early ERC with sphincterotomy group, a comparison will be made between the EUS group and the conservative group. There will be a 6 month follow-up period, which will involve participants filling in questionnaires 1, 3 and 6 months after inclusion. 3 months after inclusion there will be a follow-up visit at the outpatient clinic to assess liver and pancreatic function. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Composite of severe morbidity and mortality occurring until 6 months after inclusion. Severe morbidity is defined as the occurrence of persistent single organ failure, necrotizing pancreatitis, bacteremia, cholangitis, pneumonia or exocrine or endocrine pancreatic insufficiency. After patient inclusion is completed and after the last patient has completed the 6 month follow-up, an adjudication committee consisting of 4 gastroenterologists, 2 surgeons and 1 radiologist will assess all potential endpoints (i.e. mortality and severe complications) and decide whether these concord with definitions of the primary endpoints. Using primary source data, each member of the committee will individually assess the potential endpoints. Disagreements will be resolved at a plenary consensus meeting. |
| Secondary outcome measures | The following are assessed at 6 month follow-up. For the secondary endpoints three sources of data are used: clinical record forms that are filled out by the treating physicians, primary source data and questionnaires filled out by the patients at 1,3 and 6 month follow-up. 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. Endoscopic retrograde cholangiography (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 | 27/06/2017 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 78 evaluable patients |
| Total final enrolment | 83 |
| Key inclusion criteria | 1. Acute biliary pancreatitis 2. Predicted severe disease course 3. EUS and ERC with sphincterotomy can be performed within 24 hours after admission 4. Aged 18 years or older 5. Written informed consent 6. In case of a previous episode of necrotizing pancreatitis, patient should be fully recovered |
| Key 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. International Normalised Ratio (INR) that cannot be corrected with co-fact or fresh frozen plasma below 1.5 6. Pregnancy |
| Date of first enrolment | 15/08/2017 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Rotterdam
3015 GD
Netherlands
Dordrecht
3318 AT
Netherlands
Breda
4818 CK
Netherlands
Amsterdam
1105 AZ
Netherlands
Amsterdam
1081 HV
Netherlands
Tilburg
5042 AD
Netherlands
Rotterdam
3015 GD
Netherlands
Rotterdam
3045 PM
Netherlands
Apeldoorn
7334 DZ
Netherlands
Zwolle
8025 AB
Netherlands
Groningen
9728 NT
Netherlands
Amersfoort
Hoogland
3813 TZ
Netherlands
Enschede
7512 KZ
Netherlands
Amsterdam
1091 AC
Netherlands
Nijmegen
6525 GA
Netherlands
Delft
2625 AD
Netherlands
Haarlem
2035 RC
Netherlands
Nieuwegein
3435 CM
Netherlands
Ede
6716 RP
Netherlands
Sponsor information
Hospital/treatment centre
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| Website | www.erasmusmc.nl |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All requests for access to data generated as a result of this study should be send to M.J. Bruno (m.bruno@erasmusmc.nl) and will be reviewed by the board of the Dutch Pancreatitis Study Group to ensure scientific integrity and data protection. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/02/2023 | 28/02/2023 | Yes | No |
Editorial Notes
28/02/2023: Publication reference and total final enrolment added.
09/08/2021: The intention to publish date was changed from 01/02/2021 to 01/06/2022.
01/10/2020: The intention to publish date has been changed from 01/03/2020 to 01/02/2021.
