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Recruiting

NCT Number: NCT06260878

Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location status: Recruiting

Location contact

Nauzer Forbes, MD

CONTACT

[email protected]

403-880-8508

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Intravenous Ringer's lactate

Other

Intravenous Ringer's lactate

Primary outcomes

  1. Serum amylase

    Time frame: 24 hours

Secondary outcomes

  1. Pancreatitis

    Time frame: 7 days

    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.

  2. Bleeding

    Time frame: 30 days

    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.

  3. Cholangitis

    Time frame: 14 days

    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.

  4. Cardiorespiratory adverse event

    Time frame: 7 days

    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.

  5. Serum lipase

    Time frame: 24 hours

  6. Electrolytes

    Time frame: 24 hours

  7. Creatinine

    Time frame: 24 hours

  8. Brain natriuretic peptide

    Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Nauzer Forbes, MD, MSc

CONTACT

[email protected]

403-880-8508

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: STRIPE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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