Post-ERCP Pancreatitis
Conditions
Keywords
Post-ERCP pancreatitis, Tacrolimus, Endoscopic retrograde cholangiopancreatography, Prophylaxis, ERCP
Brief summary
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: * Does a single dose of tacrolimus lower the number of participants who develop pancreatitis after ERCP? 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: * Receive an intravenous infusion of either tacrolimus or placebo, given over 60 minutes, ending before the start of the ERCP procedure * Receive standard preventive treatment (a rectal anti-inflammatory medication (NSAID)) in addition to the study infusion * Be contacted by phone 48 hours after the procedure to check for symptoms * Complete questionnaires about quality of life and healthcare use, and be followed for 12 weeks after the procedure * The first 40 enrolled patients will have extra blood samples taken to measure tacrolimus levels.
Interventions
DRUGTacrolimus
A single intravenous dose of tacrolimus, completed before the start of ERCP.
OTHERNaCl (placebo)
A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion.
Sponsors
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Indication for ERCP * Ability to provide written informed consent
Exclusion criteria
* Previous sphincterotomy or sphincteroplasty * Routine biliary stent exchange * Altered anatomy or biliodigestive anastomosis * Chronic pancreatitis according to the M-ANNHEIM criteria * Active pancreatitis * Sepsis or ASA IV * Contraindication for tacrolimus or diclofenac (allergy, potassium \>5 mmol/L, eGFR \<30 mL/min) * Pregnancy or breastfeeding * Current tacrolimus or ciclosporin use * Current use of medications contraindicated with tacrolimus, including strong CYP3A4/3A5 inhibitors (e.g., ketoconazole, voriconazole, posaconazole, itraconazole, clarithromycin, josamycin, ritonavir, cobicistat) or CYP3A4/3A5 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP Pancreatitis (PEP) | 48 hours after ERCP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-ERCP Pancreatitis within 30 days | Within 30 days after ERCP | — |
| Severity of PEP | Up to 30 days after ERCP | Severity of Post-ERCP Pancreatitis± According to the revised Atlanta classification (mild, moderate, severe) |
| ERCP-related complications | Up to 30 days after ERCP | Incidence of ERCP-related complications other than PEP |
| Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions | Up to 30 days after ERCP | — |
| Hospital/ICU stay | Up to 12 weeks | Length of hospital and ICU stay |
| Change in quality of life as measured by EQ-5D-5L | Baseline, 48 hours, and 12 weeks after ERCP | — |
| Healthcare costs | Up to 12 weeks after ERCP | Healthcare consumption and societal costs |
Countries
Netherlands
Contacts
CONTACTMalin Witteman, MD
Outcome results
None listed