Does fishoil infusion reduce severe complications in predicted severe acute pancreatitis?
| ISRCTN | ISRCTN13860158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13860158 |
| EudraCT/CTIS number | 2022-000474-26, 2023-505220-57-03 |
| Secondary identifying numbers | 80570 |
- Submission date
- 04/02/2022
- Registration date
- 17/05/2022
- Last edited
- 04/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Acute pancreatitis is a condition where the pancreas becomes inflamed (swollen) over a short period of time. The pancreas is a small organ, located behind the stomach, that helps with digestion.
Acute pancreatitis (AP) is the most common gastrointestinal disorder requiring acute hospitalization. About 20% of all patients will develop severe acute pancreatitis often marked by a strong inflammatory response which can result in organ failure and severe complications, including mortality up to 30%.
Intravenous omega-3 fatty acids (fish oil) may ameliorate the inflammatory response. We hypothesize that the anti-inflammatory function of fish oil could attenuate reduce the severity of acute pancreatitis and improve outcome and survival.
The PLANCTON trial will investigate the effect of early fish oil infusion on new onset organ failure and mortality in patients with predicted severe acute pancreatitis.
Who can participate?
Adult patients with a first episode of predicted severe acute pancreatitis.
What does the study involve?
Patients will be randomized as early as possible after the diagnosis of acute pancreatitis (within 24 hours of diagnosis and within 72 hours after onset of symptoms) between fish oil or standard medical care.
When randomized for fish oil standard medical care is provided and intravenous administration of a lipid emulsion (0.2g/kg/day) with fish oil for a total of 7 days.
What are the possible benefits and risks of participating?
The burden for participants in this study is limited. The risk of fish oil administration is estimated to be negligible because (serious) adverse events were not described in published trials. Additionally, the known side effects of fish oil are rare. The intravenous administration of fish oil and questionnaires can be marked as a (small) burden in addition to standard medical care. The benefit for (future) patients treated with fish oil could be substantial with a reduction in new onset organ failure and mortality in a very serious disease.
Where is the study run from?
The study will be run by the Dutch Pancreatitis Study Group (located at St. Antonius Hospital, Nieuwegein, the Netherlands).
When is the study starting and how long is it expected to run for?
January 2021 to February 2026
Who is funding the study?
Radboud Universitair Medisch Centrum (the Netherlands)
Fresenius Kabi (the Netherlands)
Who is the main contact?
Dr Martijn W.J. Stommel, Martijn.stommel@radboudumc.nl
Contact information
Principal Investigator
Radboud University Medical Center
Geert Grooteplein Zuid 10
Nijmegen
Maastricht
6525 GA
Netherlands
 ORCID ID |
0000-0002-4257-5254 |
|---|---|
| Phone | +31(0)24-3617365 |
| Martijn.stommel@radboudumc.nl |
Scientific
Radboud University Medical Center
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
| ORCID ID |
0000-0002-7814-9548 |
|---|---|
| Phone | +31(0)88 3208653 |
| a.nagelhout@antoniusziekenhuis.nl |
Study information
| Study design | Multicenter randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled 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 | Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON trial) |
| Study acronym | PLANCTON |
| Study objectives | Based on the literature, there seems to be a relation in acute pancreatitis between (hyper)inflammation, SIRS, new onset of organ failure and mortality. Omega-3 fatty acids seem to have clinical beneficial effects through immunomodulation, supported by the decreased inflammatory biomarkers in patients with acute pancreatitis. Therefore, the following hypothesis was formulated: Early intravenous administration of omega-3 fatty acids reduces the composite endpoint of new onset organ failure and/or mortality in patients with predicted severe acute pancreatitis. |
| Ethics approval(s) | Approved 09/05/2022, Radboud University Medical Center (P.O. Box 9101, 6500 HB Nijmegen, The Netherlands; +31 24 361 89 33; no email provided), ref: NL80570.091.22 |
| Health condition(s) or problem(s) studied | Predicted severe acute pancreatitis |
| Intervention | Participants are randomised to one of two groups using an online tool. Intervention: Intravenous administration of a lipid emulsion (0.2 g/kg/day) with OM-3 FAs, started within 24 hours of diagnosis of predicted SAP and within 72 hours after onset of symptoms of AP, for a total of 7 days. Control: Standard medical care |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Omegaven |
| Primary outcome measure | New onset of organ failure (organ failure not present at randomization) and mortality measured using patient notes during 6 months follow-up |
| Secondary outcome measures | 1. Severe complications (([infected] pancreas necrosis, sepsis, pneumonia or cholangitis) measured using patient notes during 6 months follow-up 2. Quality of life measured using questionnaires at hospital discharge, 3 months and 6 months follow-up 3. Cost effectiveness measured using questionnaires at hospital discharge, 3 months and 6 months follow-up 4. Number of (surgical, endoscopic or radiologic) interventions measured using patient notes during 6 months follow-up 5. Length of hospital and ICU stay measured using using patient notes during 6 months follow-up |
| Overall study start date | 01/01/2021 |
| Completion date | 01/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 212 |
| Key inclusion criteria | 1. Predicted severe acute pancreatitis 2. ≥18 years old 3. First episode of acute pancreatitis 4. <24 hours after diagnosis of acute pancreatitis 5. <72 hours after onset of symptoms of acute pancreatitis 6. Able to read and/or understand the study procedures 7. Able to give informed consent (or their legal representatives) |
| Key exclusion criteria | Current participant exclusion criteria as of 01/11/2023: 1. Intake of omega-3 fatty acids 2. Participation in another intervention study for acute pancreatitis 3. Organ failure on admission (Modified Marshall score >2) 4. Recurrent pancreatitis 5. Chronic pancreatitis. Defined by the MANNHEIM criteria 6. Known allergy to fish oil, seafood, soja, or egg products 7. History or existing hyperlipidemia (laboratory-proven triglycerides >10.0 mmol/l) 8. History of (severe) liver failure. Based on coagulation Factor V level or INR >3 9. (without anti-coagulation by vitamin K) 10. Ketoacidosis 11. Acute thrombo-embolic disease 12. Pregnancy or lactation 13. Recent (<6 months) myocardial infarction or stroke 14. Known coagulation disorders (e.g. Factor V Leiden, thrombocytopenia, etc.) 15. Pancreatitis due to a (suspected) periampullary/ampullary or bile duct malignancy 16. Other known or suspected malignancy that may interfere with the outcome(s) and/or execution of the PLANCTON trial 17. Post ERCP-pancreatitis due to a (suspected) malignancy 18. Patient is classified as moribund or expected to die within 24 hours Previous participant exclusion criteria: 1. Intake of omega-3 fatty acids 2. Participation in another intervention study for acute pancreatitis 3. Organ failure on admission (Modified Marshall score >2) 4. Recurrent pancreatitis 5. Chronic pancreatitis. Defined by the MANNHEIM criteria 6. Known allergy to fish oil, seafood, soja, or egg products 7. History or existing hyperlipidemia (laboratory-proven triglycerides >10.0 mmol/l) 8. History of (severe) liver failure. Based on coagulation Factor V level or INR >3 9. (without anti-coagulation by vitamin K) 10. Ketoacidosis 11. Acute thrombo-embolic disease 12. Pregnancy or lactation 13. Recent (<6 months) myocardial infarction or stroke 14. Known coagulation disorders (e.g. Factor V Leiden, thrombocytopenia, etc.) 15. Patient is classified as moribund or expected to die within 24 hours |
| Date of first enrolment | 15/07/2022 |
| Date of final enrolment | 01/12/2026 |
Locations
Countries of recruitment
- Denmark
- Netherlands
Study participating centres
6525 GA
Netherlands
1105 AZ
Netherlands
6229 HC
Netherlands
3015 GD
Netherlands
2333 ZA
Netherlands
4708 AE
Netherlands
5623 EJ
Netherlands
6532 SZ
Netherlands
2545 AA
Netherlands
5223 GZ
Netherlands
3813 TZ
Netherlands
7512 KZ
Netherlands
6716 RP
Netherlands
2650
Denmark
Sponsor information
Hospital/treatment centre
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
| Phone | +31 (0)24-3617365 |
|---|---|
| Martijn.stommel@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
- Location
- Netherlands
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Fresenius Kabi AG, Fresenius Kabi Deutschland GmbH
- Location
- Germany
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | After the publication of all the results of the trial, anonymous data can be shared depending on the purpose of the application and the research question. Enquiries can be sent to Dr. M.W.J. Stommel, surgeon, Radboud University Medical Center, Nijmegen, The Netherlands (martijn.stommel@radboudumc.nl). |
Editorial Notes
04/06/2025: The following changes were made to the study record:
1. EudraCT/CTIS number and study website added.
2. The recruitment end date was changed from 01/08/2025 to 01/12/2026.
3. Denmark was added to the countries of recruitment.
4. The study participating centres were updated to add Bravis Hospital, Catharina Hospital, CWZ, Haga Hospital, Jeroen Bosch Hospital, Meander Medical Center, MST, ZGV and Hvidovre Hospital.
5. IPD sharing plan updated.
6. The intention to publish date was changed from 01/08/2026 to 01/06/2027.
03/06/2025: Contact/sponsor details updated.
01/11/2023: The participant exclusion criteria were changed.
18/10/2022: A scientific contact has been added.
28/09/2022: The recruitment start date was changed from 01/06/2022 to 15/07/2022.
17/05/2022: Trial's existence confirmed by Radboud UMC
