Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial)

ISRCTN	ISRCTN33682933
DOI	https://doi.org/10.1186/ISRCTN33682933
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	N/A
Sponsor	Academic Medical Center
Funder	Fonds NutsOhra

Submission date: 02/07/2015
Registration date: 06/08/2015
Last edited: 02/09/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 Amsterdam UMC, location Academic Medical Center Amsterdam.

Who is the main contact?
1. Dr Lotte Boxhoorn
L.boxhoorn@amsterdamumc.nl
2. Dr Marc Besselink
m.g.besselink@amsterdamumc.nl

Contact information

Prof Marc Besselink
Scientific

Amsterdam UMC, location VUMC
Department of Surgery
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31-20-4444400
Email	m.g.besselink@amsterdamumc.nl

Dr Lotte Boxhoorn
Scientific

St. Antonius Hospital
Dutch Pancreatitis Study Group
Nieuwegein
PO Box 2500 / 3430 EM
Netherlands

Phone	+31 (0)88 3207053
Email	L.boxhoorn@amsterdamumc.nl

Study information

Primary study design	Interventional
Study design	Pragmatic parallel-group randomized controlled multicenter superiority trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Postponed or immediate drainage of infected necrotizing pancreatitis: a pragmatic parallel group randomized controlled multicenter superiority trial
Study acronym	POINTER trial
Study objectives	Immediate catheter drainage is clinically and economically superior to postponed catheter drainage within the step-up approach in infected necrotizing pancreatitis.
Ethics approval(s)	The medical ethics committee of the Amsterdam UMC, location Academic Medical Center Amsterdam, 19/06/2015, NL52361.018.15
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Current primary outcome measure as of 12/04/2021: Comprehensive Complication Index (CCI), including all complications other than pre-existent complications (e.g. treatment for infected (extra) pancreatic necrosis) occurring after randomization until 6 months after randomization, and graded according to the Clavien-Dindo classification. Previous primary outcome measure: The Comprehensive Complication Index (CCI), including all complications between randomization and 6 months after
Key secondary outcome measure(s)	Current secondary outcome measures as of 12/04/2021: 1. Mortality 2. New onset (multi-)organ failure 3. Bleeding requiring intervention 4. Perforation of a visceral organ requiring intervention 5. Enterocutaneous fistula 6. Pancreaticocutaneous fistula 7. Incisional hernia 8. Wound infections 9. Endocrine and exocrine pancreas insufficiency 10. Number of patients with severe complications (Clavien-Dindo III or higher) 11. Number of patients per Clavien-Dindo classification 12. Number of surgical, endoscopic and radiologic interventions 13. Length of hospital stay 14. Length of ICU admission 15. QALYs 16. Total direct and indirect costs 17. Budget impact All secondary endpoints occurring within 6 months after randomization will be measured Previous 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.
Completion date	11/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	104
Total final enrolment	104
Key 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
Key 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
Date of first enrolment	04/08/2015
Date of final enrolment	11/10/2019

Locations

Countries of recruitment

Netherlands

Study participating centres

Amsterdam UMC, location Academic Medical Center

Amsterdam
-
Netherlands

Erasmus Medical Center

Rotterdam
-
Netherlands

St. Antonius Hospital

Nieuwegein
-
Netherlands

Maastricht University Medical Center

Maastricht
-
Netherlands

Radboudumc

Nijmegen
-
Netherlands

University Medical Center Groningen

Groningen
-
Netherlands

University Medical Center Utrecht

Utrecht
-
Netherlands

Jeroen Bosch Hospital

’s-Hertogenbosch
-
Netherlands

Reinier de Graaf Gasthuis

Delft
-
Netherlands

Amsterdam UMC, location VU University Medical Center

Amsterdam
-
Netherlands

Meander Medical Center

Amersfoort
-
Netherlands

Hospital Gelderse Vallei

Ede
-
Netherlands

Maxima Medisch Centrum

Veldhoven
-
Netherlands

Isala Klinieken

Zwolle
-
Netherlands

Rijnstate Hospital

Arnhem
-
Netherlands

Medisch Spectrum Twente

Enschede
-
Netherlands

Catharina Hospital

Eindhoven
-
Netherlands

Gelre Hospital

Apeldoorn
-
Netherlands

Medical Center Leeuwarden

Leeuwarden
-
Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam
-
Netherlands

Amphia Hospital

Breda
-
Netherlands

Maasstad Hospital

Rotterdam
-
Netherlands

Spaarne Gasthuis

Haarlem
-
Netherlands

Albert Schweitzer Hospital

Dordrecht
-
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. dr. Marc Besselink (m.g.besselink@amsterdamumc.nl)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		07/10/2021	07/10/2021	Yes	No
Results article		17/07/2023	17/07/2023	Yes	No
Protocol article	protocol	25/04/2019	29/04/2019	Yes	No
Other publications	Secondary analysis	25/04/2025	02/09/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

02/09/2025: Publication reference added.
17/07/2023: Publication reference added.
07/10/2021: Publication reference added.
13/09/2021: One of the scientific contact's phone number has been changed.
10/09/2021: The study contact has been updated.
24/08/2021: The intention to publish date was changed from 01/08/2021 to 01/10/2021.
08/06/2021: The intention to publish date was updated from 01/06/2021 to 01/08/2021. Total final enrolment added.
14/04/2021: A typographical error was corrected.
12/04/2021: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
3. The publication and dissemination plan, was updated.
4. The intention to publish date was changed from 01/12/2020 to 01/06/2021.
16/04/2020: The scientific contacts have been updated and the plain English summary has been updated to reflect this.
14/01/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2019 to 11/10/2019.
2. The overall end date was changed from 01/06/2020 to 11/04/2019.
3. The intention to publish date was added.
29/04/2019: Publication reference added.
12/09/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2018 to 01/12/2019.
2. The overall trial end date was changed from 31/12/2018 to 01/06/2020.