Plain English Summary
Background and study aims
Acute pancreatitis is a common disease where the pancreas becomes inflamed over a short period of time. During an acute pancreatitis attack, tissue within the pancreas may die (necrotize) and later become infected. Infected necrosis is associated with a mortality (death rate) of 20% and many other complications. Current guidelines recommend a so-called ‘step-up approach’ in these patients, starting with first catheter drainage. If necessary, patients will have an additional operation to remove their infected necrosis (necrosectomy). All these interventions are preferably delayed until the necrotic collections have reached the stage of walled-off necrosis. This process usually takes 4 weeks. During this waiting period antibiotic treatment is used. There is evidence that necrosectomy (second step) should be postponed until walled-off necrosis. However, evidence regarding the best timing of catheter drainage (first step) is lacking. This study aims to compare immediate and postponed catheter drainage in patients with infected necrotizing pancreatitis with regard to clinical outcomes and medical costs.
Who can participate?
Adult patients with (suspected) infected necrotizing pancreatitis.
What does the study involve?
Participants will be randomly allocated to either the intervention or the control group. Participants will undergo the same treatment as non-participating patients. The only difference is that participants in the intervention group will undergo catheter drainage earlier in the disease course. Participants will attend follow-up visits 3 and 6 months later to undergo routine tests (e.g., pancreatic function tests and imaging).
What are the possible benefits and risks of participating?
There is a rationale in postponing catheter drainage in patients with infected necrotizing pancreatitis. First, antibiotic treatment alone may suffice as treatment. Second, diagnosing infected necrotizing pancreatitis is often easier in a later stage of the disease. Third, catheter drainage may be easier once the stage of walled-off necrosis has been reached. On the other hand there is not always a technical reason to wait several weeks until full encapsulation of the collections and catheter drainage can be performed successfully in the first weeks after onset of disease. For similar abdominal conditions catheter drainage is also safely performed early in ‘non-walled-off’ collections. If there is no technical reason for postponing catheter drainage, patients with infected necrotizing pancreatitis may benefit from earlier catheter drainage by reduced complications and length of hospital stay.
Where is the study run from?
The study is initiated by the Dutch Pancreatitis Study Group (DPSG) and 24 Dutch hospitals will participate.
When is the study starting and how long is it expected to run for?
The study will start in July 2015 and will run for 3 years. Thereafter the follow-up will be completed in 6 months, followed by 6 months for data collecting, analysing and reporting. The total duration of the study is 4 years.
Who is funding the study?
Fonds NutsOhra and the Academic Medical Center Amsterdam.
Who is the main contact?
1. Dr Sven van Dijk
s.vandijk@pancreatitis.nl
2. Dr Marc Besselink
m.g.besselink@amc.uva.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marc Besselink
ORCID ID
Contact details
Academic Medical Center
Dept. of Surgery
Amsterdam
PO Box 22660 / 1100 DD
Netherlands
+31 (0)205 669 111
m.g.besselink@amc.nl
Type
Scientific
Additional contact
Dr Sven van Dijk
ORCID ID
Contact details
St. Antonius Hospital
Dutch Pancreatitis Study Group
Nieuwegein
PO Box 2500 / 3430 EM
Netherlands
+31 (0)88 3207052
s.vandijk@pancreatitis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Postponed or immediate drainage of infected necrotizing pancreatitis: a pragmatic parallel group randomized controlled multicenter superiority trial
Acronym
POINTER trial
Study hypothesis
Immediate catheter drainage is clinically and economically superior to postponed catheter drainage within the step-up approach in infected necrotizing pancreatitis.
Ethics approval
The medical ethics committee of the Academic Medical Center Amsterdam, 19/06/2015, NL52361.018.15
Study design
Pragmatic parallel-group randomized controlled multicenter superiority trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Infected necrotizing pancreatitis
Intervention
Immediate catheter drainage after diagnosing infected necrosis while starting antibiotic treatment versus current standard treatment with postponing catheter drainage under antibiotic treatment (preferably until walled-off necrosis). If necessary a necrosectomy will be performed and postponed, if feasible, until the stage of walled-off necrosis in both treatment arms.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
The Comprehensive Complication Index (CCI), including all complications between randomization and 6 months after
Secondary outcome measures
1. Mortality
2. New onset (multi-)organ failure
3. Bleeding requiring intervention
4. Perforation requiring intervention
5. Fistula
6. Incisional hernia
7. Wound infections
8. Endocrine and exocrine pancreas insufficiency
9. Number of patients with severe complications (Clavien-Dindo III or higher)
10. Number of patients per Clavien-Dindo classification
11. Number of (re-)interventions
12. Hospital and ICU length of stay
13. QALYs
14. (In)direct costs
15. Budget impact
All secondary endpoints occurring within 6 months after randomization will be measured.
Overall trial start date
01/07/2015
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients with (suspected) infected necrotizing pancreatitis; all patients with necrotizing pancreatitis will be screened for eligibility including a protocolized approach to patients with signs of infection
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
104
Participant exclusion criteria
1. More than 35 days after onset of acute pancreatitis
2. Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome)
3. Previous retroperitoneal intervention for necrotizing pancreatitis
4. Documented chronic pancreatitis
Recruitment start date
04/08/2015
Recruitment end date
01/07/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
-
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
-
Netherlands
Trial participating centre
St. Antonius Hospital
Nieuwegein
-
Netherlands
Trial participating centre
Maastricht University Medical Center
Maastricht
-
Netherlands
Trial participating centre
Radboudumc
Nijmegen
-
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
-
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
-
Netherlands
Trial participating centre
Jeroen Bosch Hospital
’s-Hertogenbosch
-
Netherlands
Trial participating centre
Reinier de Graaf Gasthuis
Delft
-
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
-
Netherlands
Trial participating centre
Meander Medical Center
Amersfoort
-
Netherlands
Trial participating centre
Hospital Gelderse Vallei
Ede
-
Netherlands
Trial participating centre
Maxima Medisch Centrum
Veldhoven
-
Netherlands
Trial participating centre
Isala Klinieken
Zwolle
-
Netherlands
Trial participating centre
Rijnstate Hospital
Arnhem
-
Netherlands
Trial participating centre
Medisch Spectrum Twente
Enschede
-
Netherlands
Trial participating centre
Catharina Hospital
Eindhoven
-
Netherlands
Trial participating centre
Gelre Hospital
Apeldoorn
-
Netherlands
Trial participating centre
Medical Center Leeuwarden
Leeuwarden
-
Netherlands
Trial participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
-
Netherlands
Trial participating centre
Amphia Hospital
Breda
-
Netherlands
Trial participating centre
Maasstad Hospital
Rotterdam
-
Netherlands
Trial participating centre
Spaarne Gasthuis
Haarlem
-
Netherlands
Trial participating centre
Albert Schweitzer Hospital
Dordrecht
-
Netherlands
Funders
Funder type
Charity
Funder name
Fonds NutsOhra
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed on a later date
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Marc Besselink (m.g.besselink@amc.uva.nl)
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary