Condition category
Digestive System
Date applied
02/07/2015
Date assigned
06/08/2015
Last edited
11/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
Janneke van Grinsven (MD), j.vangrinsven@pancreatitis.nl
Marc Besselink (MD MSc PhD), m.g.besselink@amc.uva.nl

Trial website

www.pancreatitis.nl

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 Janneke van Grinsven

ORCID ID

Contact details

St. Antonius Hospital
Dutch Pancreatitis Study Group
Nieuwegein
PO Box 2500 / 3430 EM
Netherlands
+31 (0)306 098 309
j.vangrinsven@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

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

Sponsor information

Organisation

Academic Medical Center

Sponsor details

Meibergdreef 9
Amsterdam
PO Box 22660 / 1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes