Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial)
| ISRCTN | ISRCTN33682933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33682933 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/07/2015
- Registration date
- 06/08/2015
- Last edited
- 17/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Scientific
Amsterdam UMC, location VUMC
Department of Surgery
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31-20-4444400 |
|---|---|
| m.g.besselink@amsterdamumc.nl |
Scientific
St. Antonius Hospital
Dutch Pancreatitis Study Group
Nieuwegein
PO Box 2500 / 3430 EM
Netherlands
| Phone | +31 (0)88 3207053 |
|---|---|
| L.boxhoorn@amsterdamumc.nl |
Study information
| Study design | Pragmatic parallel-group randomized controlled multicenter superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2015 |
| Completion date | 11/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
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Study participating centres
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Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
PO Box 22660 / 1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan, as of 12/04/2021: Planned publication in a high-impact peer-reviewed journal. |
| 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) Previous 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/04/2019 | 29/04/2019 | Yes | No |
| Results article | 07/10/2021 | 07/10/2021 | Yes | No | |
| Results article | 17/07/2023 | 17/07/2023 | Yes | No |
Editorial Notes
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.
