Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

Phase 4Not Yet RecruitingNCT07781722

Amsterdam UMC, location VUmc520 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

520

Conditions

Post-ERCP Pancreatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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

Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts