Post-ERCP Acute PancreatitisPhase 4STRIPENCT06260878
Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
A Phase 4 study testing Intravenous Ringer's lactate in people with Post-ERCP Acute Pancreatitis, run by University of Calgary at 1 site in Canada.
Trial summary
This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Intravenous Ringer's lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2024to 31 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients >75 years of age)
- ability to give informed consent
- native major papillary anatomy
- ability and willingness to obtain bloodwork the day after ERCP
Who cannot join
- prior ERCP with sphincterotomy and/or sphincteroplasty
- confirmed or suspected cholangitis or sepsis
- confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
- NYHA Class II or greater heart failure
- active pulmonary edema
- myocardial infarction or ischemia within the preceding 3 months
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- renal insufficiency with CrCl < 40 mL/minute
- CPT Class B or C cirrhosis and/or end-stage liver disease
- room air oxygen saturation <90% or requirement of home O2
- hypernatremia with Na+ ≥ 150 mEq/L or Na+ <130 mEq/L
- uncontrolled hypertension or hypotension
- pregnant status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Nauzer Forbes, MD, 403-880-8508, nauzer.forbes@ucalgary.ca
About this study
This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Intravenous Ringer's lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Ringer's lactateOther
Intravenous Ringer's lactate
| Study group | Role | What they receive |
|---|---|---|
| Ringer's lactate 2500 cc IV | Experimental | Not described Receives: Other: Intravenous Ringer's lactate |
| Ringer's lactate 2000 cc IV | Experimental | Not described Receives: Other: Intravenous Ringer's lactate |
| Ringer's lactate 1500 cc IV | Experimental | Not described Receives: Other: Intravenous Ringer's lactate |
| Ringer's lactate 1000 cc IV | Experimental | Not described Receives: Other: Intravenous Ringer's lactate |
| Ringer's lactate 500 cc IV | Active comparator | Not described Receives: Other: Intravenous Ringer's lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum amylase
Measured: 24 hours
Secondary outcomes (8)
Pancreatitis
Abdominal pain characteristic of pancreatitis occurring after ERCP resulting in admission of (or prolongation of admission by) at least 2 nights, with one or more of: (1) amylase and/or lipase > 3 times the upper limit of normal when measured at least the day after ERCP and/or (2) imaging findings characteristic of pancreatitis.
Measured: 7 days
Bleeding
Hematemesis, melena, or hematochezia (other than blood on toilet paper) resulting in one or more of the following: (1) hemoglobin drop > 2g and/or a need for transfusion, (2) a procedure performed for evaluation of suspected bleeding, and/or (3) emergency department visit and/or admission to hospital and/or prolongation of existing admission by at least one night.
Measured: 30 days
Cholangitis
Presentation that includes all of the following: (1) temperature < 36.0°C or > 38.0°C or white blood cell count < 4,000/L or > 10,000/L and (2) increase in bilirubin, alkaline phosphatase, or transaminases compared to pre-procedure, or, if previously normal, a rise in any parameter to > 1.5 times the upper limit of normal, and (3) emergency department visit and/or admission to hospital and/or prolongation of existing admission by at least one night.
Measured: 14 days
Cardiorespiratory adverse event
Cardiorespiratory signs and/or symptoms related to a non-gastrointestinal organ system, or sedation- or drug-related reaction occurring during or after ERCP. The event must (1) result in an unplanned emergency department visit, hospital admission, or prolongation of existing admission by at least one night and/or (2) prevent completion of the planned procedure and/or (3) result in death.
Measured: 7 days
Serum lipase
Measured: 24 hours
Electrolytes
Measured: 24 hours
Creatinine
Measured: 24 hours
Brain natriuretic peptide
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start22 Nov 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260878
- Sponsor's protocol ID
- REB23-0625
- Acronym
- STRIPE
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Forbes N, Guo H, Kruk A, Ficaccio S, Cartwright S, Howarth M, Malik G, Nietert PJ, Smith ZL, Li S, Chen YI, Causada Calo N, Tse F, Telford JJ, Cook DJ, Hill MD, Elmunzer BJ. Short-term intravenous fluids for prevention of post-ERCP pancreatitis (the STRIPE study): protocol for a five-arm randomised controlled trial. BMJ Open. 2026 May 27;16(5):e119154. doi: 10.1136/bmjopen-2026-119154.
PubMed 42203288
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT06260878
- Acronym / sponsor ID
- STRIPE / REB23-0625
- Conditions
- Post-ERCP Acute Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Feb 2024 (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.
This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ringer's lactate 2500 cc IV | Experimental | Other: Intravenous Ringer's lactate |
| Ringer's lactate 2000 cc IV | Experimental | Other: Intravenous Ringer's lactate |
| Ringer's lactate 1500 cc IV | Experimental | Other: Intravenous Ringer's lactate |
| Ringer's lactate 1000 cc IV | Experimental | Other: Intravenous Ringer's lactate |
| Ringer's lactate 500 cc IV | Active comparator | Other: Intravenous Ringer's lactate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients >75 years of age)
- ability to give informed consent
- native major papillary anatomy
- ability and willingness to obtain bloodwork the day after ERCP
Key exclusion criteria (12 listed)
- prior ERCP with sphincterotomy and/or sphincteroplasty
- confirmed or suspected cholangitis or sepsis
- confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
- NYHA Class II or greater heart failure
- active pulmonary edema
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 |
|---|---|---|
| Intravenous Ringer's lactateIntravenous Ringer's lactate | Other | Ringer's lactate 1000 cc IV, Ringer's lactate 1500 cc IV, Ringer's lactate 2000 cc IV, Ringer's lactate 2500 cc IV, Ringer's lactate 500 cc IV |
Primary outcome
Serum amylase
Time frame: 24 hours
8 secondary outcomes
Pancreatitis
Time frame: 7 days
Bleeding
Time frame: 30 days
Cholangitis
Time frame: 14 days
Cardiorespiratory adverse event
Time frame: 7 days
Serum lipase
Time frame: 24 hours
Electrolytes
Time frame: 24 hours
Creatinine
Time frame: 24 hours
Brain natriuretic peptide
Time frame: 24 hours
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 29 Apr 2026.
- Derived from this study: PubMed 42203288Forbes N, Guo H, Kruk A, Ficaccio S, Cartwright S, Howarth M, Malik G, Nietert PJ, Smith ZL, Li S, Chen YI, Causada Calo N, Tse F, Telford JJ, Cook DJ, Hill MD, Elmunzer BJ. Short-term intravenous fluids for prevention of post-ERCP pancreatitis (the STRIPE study): protocol for a five-arm randomised controlled trial. BMJ Open. 2026 May 27;16(5):e119154. doi: 10.1136/bmjopen-2026-119154.
- Individual participant dataSharing planned: Undecided
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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 Intravenous Ringer's lactate in people with Post-ERCP Acute Pancreatitis, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 29 Apr 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 Canada. 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. 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 Nauzer Forbes, MD, MSc (403-880-8508, nauzer.forbes@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum amylase (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260878, which also lists 1 linked publication.
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 29 Apr 2026.