Condition category
Digestive System
Date applied
13/11/2012
Date assigned
17/12/2012
Last edited
06/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof M.J. Bruno

ORCID ID

Contact details

Erasmus Medical Center
Department of Gastroenterology and Hepatology
s-Gravendijkwal 230
Rotterdam
3015CE
Netherlands
+31 (0)10 703 5946
m.bruno@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acute biliary Pancreatitis: early Endoscopic retrograde cholangiography plus sphincterotomy versus Conservative treatment (APEC trial): a randomized, superiority, assessor-blinded multicenter trial

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

Erasmus Medical Center Rotterdam Ethics Committee, 08/11/2012 ref: MEC-2012-357

Study design

Randomized superiority assessor-blinded multicenter trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at http://www.pancreatitis.nl/

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2012

Overall trial end date

31/10/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

232 patients

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

Trial participating centre

Erasmus Medical Center
Rotterdam
3015CE
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (Netherlands)

Sponsor details

Dutch Pancreatitis Study Group
Department of Gastroenterology and Hepatology
s-Gravendijkwal 230
Rotterdam
3015CE
Netherlands
+31 (0)61 441 1960
m.bruno@erasmusmc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl

Funders

Funder type

Charity

Funder name

Fonds NutsOhra (Netherlands) ref: 1203-052

Alternative name(s)

Stichting Nuts Ohra, NutsOhra Foundation, NutsOhra Fund

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Pancreas Society (Alvleeskliervereniging) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Erasmus Medisch Centrum

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26729193

Publication citations

Additional files

Editorial Notes