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Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

ConditionPost-ERCP Pancreatitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older

Indication for ERCP

Ability to provide written informed consent

Disqualifiers

Previous sphincterotomy or sphincteroplasty

Routine biliary stent exchange

Altered anatomy or biliodigestive anastomosis

Chronic pancreatitis according to the M-ANNHEIM criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tacrolimus

    Drug

    A single intravenous dose of tacrolimus, completed before the start of ERCP.

  • NaCl (placebo)

    Other intervention

    A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion.

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: TacrolimusExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Incidence of Post-ERCP Pancreatitis within 30 days

Time frame
Within 30 days after ERCP
2

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
3

ERCP-related complications

Incidence of ERCP-related complications other than PEP

Time frame
Up to 30 days after ERCP
4

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions

Time frame
Up to 30 days after ERCP

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC, location VUmc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: