Post-ERCP PancreatitisPhase 4TacroProphNCT07781722
Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis
A Phase 4 study testing Tacrolimus in people with Post-ERCP Pancreatitis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- Tacrolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2026to 7 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Indication for ERCP
- Ability to provide written informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC, Location VUmc
Amsterdam
Malin Witteman, 088-3207054, m.witteman1@amsterdamumc.nl
Mattheus Wielenga, MD PhD
About this study
Official title: Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis: a DPSG (Dutch Pancreatitis Study Group) Multicenter, Double-blind, Randomized, Placebo-controlled Study.
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:
Read more
- 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.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- Tacrolimus, NaCl (placebo)
- Keywords
- Post-ERCP pancreatitis, Tacrolimus, Endoscopic retrograde cholangiopancreatography, Prophylaxis, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
A single intravenous dose of tacrolimus, completed before the start of ERCP.
NaCl (placebo)Other
A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Experimental | 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. Receives: Drug: Tacrolimus |
| Placebo | Placebo comparator | 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. Receives: Other: NaCl (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after ERCP
Secondary outcomes (7)
Incidence of Post-ERCP Pancreatitis within 30 days
Measured: Within 30 days after ERCP
Severity of PEP
Severity of Post-ERCP Pancreatitis± According to the revised Atlanta classification (mild, moderate, severe)
Measured: Up to 30 days after ERCP
ERCP-related complications
Incidence of ERCP-related complications other than PEP
Measured: Up to 30 days after ERCP
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions
Measured: Up to 30 days after ERCP
Hospital/ICU stay
Length of hospital and ICU stay
Measured: Up to 12 weeks
Change in quality of life as measured by EQ-5D-5L
Measured: Baseline, 48 hours, and 12 weeks after ERCP
Healthcare costs
Healthcare consumption and societal costs
Measured: Up to 12 weeks after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completion7 Sep 2028 (estimated)
- Study completion7 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP PancreatitisStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattheus Wielenga, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781722
- Sponsor's protocol ID
- 2025-522900-26-00
- Other IDs
- 10140262310007, 2025-522900-26-00, 2025
- Acronym
- TacroProph
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis: a DPSG (Dutch Pancreatitis Study Group) Multicenter, Double-blind, Randomized, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT07781722
- Acronym / sponsor ID
- TacroProph / 2025-522900-26-00
- Conditions
- Post-ERCP Pancreatitis
- Keywords
- Post-ERCP pancreatitis, Tacrolimus, Endoscopic retrograde cholangiopancreatography, Prophylaxis, ERCP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 7 Sep 2028 (estimated)
- Study completion
- 7 Dec 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Experimental | Drug: TacrolimusParticipants 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. |
| Placebo | Placebo comparator | Other: NaCl (placebo)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Indication for ERCP
- Ability to provide written informed consent
Key exclusion criteria (10 listed)
- Previous sphincterotomy or sphincteroplasty
- Routine biliary stent exchange
- Altered anatomy or biliodigestive anastomosis
- Chronic pancreatitis according to the M-ANNHEIM criteria
- Active pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusA single intravenous dose of tacrolimus, completed before the start of ERCP. | Drug | Tacrolimus |
| NaCl (placebo)A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion. | Other | Placebo |
Primary outcome
Post-ERCP Pancreatitis (PEP)
Time frame: 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.
7 secondary outcomes
Incidence of Post-ERCP Pancreatitis within 30 days
Time frame: Within 30 days after ERCP
Severity of PEP
Time frame: Up to 30 days after ERCP
ERCP-related complications
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
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
Time frame: Up to 12 weeks after ERCP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Post-ERCP Pancreatitis
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
Not yet recruiting
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
Recruiting
Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with Post-ERCP Pancreatitis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malin Witteman, MD (+31 88 3207054, m.witteman1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ERCP Pancreatitis (PEP) (time frame: 48 hours after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.