A Phase 4 interventional study of Tacrolimus and NaCl (placebo) in Post-ERCP Pancreatitis, sponsored by Amsterdam UMC, location VUmc. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Amsterdam UMC, location VUmc · Phase 4, Interventional, and Prevention
The goal of this clinical trial is to learn if a single intravenous dose of tacrolimus, given before an ERCP procedure (an endoscopic procedure of the bile ducts and pancreas), can prevent post-ERCP pancreatitis (PEP) in adults at moderate-to-high risk of developing this complication.
The main question it aims to answer is:
Researchers will compare tacrolimus to a placebo (a look-alike solution with no active drug) to see if tacrolimus reduces the occurrence of PEP.
Participants will:
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 520 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a single intravenous dose of tacrolimus, completed before the start of ERCP. All participants also receive standard prophylactic care with rectal diclofenac 100 mg.
Drug: Tacrolimus
Participants receive a matching intravenous placebo, identical in appearance and administration to the tacrolimus arm. All participants also receive standard prophylactic care with rectal diclofenac 100 mg.
Other: NaCl (placebo)
A single intravenous dose of tacrolimus, completed before the start of ERCP.
A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion.
Post-ERCP Pancreatitis (PEP)
Occurrence of post-ERCP pancreatitis within 48 hours after ERCP, defined according to the revised Atlanta criteria: ≥2 of the following: (a) characteristic abdominal pain; (b) serum amylase or lipase \>3× upper limit of normal; (c) imaging findings consistent with pancreatitis.
Time frame: 48 hours after ERCP
Incidence of Post-ERCP Pancreatitis within 30 days
Time frame: Within 30 days after ERCP
Severity of PEP
Severity of Post-ERCP Pancreatitis± According to the revised Atlanta classification (mild, moderate, severe)
Time frame: Up to 30 days after ERCP
ERCP-related complications
Incidence of ERCP-related complications other than PEP
Time frame: Up to 30 days after ERCP
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions
Time frame: Up to 30 days after ERCP
Hospital/ICU stay
Length of hospital and ICU stay
Time frame: Up to 12 weeks
Change in quality of life as measured by EQ-5D-5L
Time frame: Baseline, 48 hours, and 12 weeks after ERCP
Healthcare costs
Healthcare consumption and societal costs
Time frame: Up to 12 weeks after ERCP
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus
Amsterdam UMC, location VUmc →