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Not yet recruiting NCT03215862

Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

No phase Interventional Post-ERCP Acute Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactated Ringer, Normal Saline 0.9% Infusion Solution Bag.
Who it may be relevant to
Registry conditions: Post-ERCP Acute Pancreatitis. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Overview

This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.

Interventions

  • Drug Lactated Ringer
    This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
  • Drug Normal Saline 0.9% Infusion Solution Bag
    This is a Normal Saline solution infusion before, during, and after the ERCP procedure.

Primary outcome measures

  • Post-ercp pancreatitis [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk:

  • Suspicion of Oddi dysfunction
  • Personal history of post-ERCP pancreatitis
  • More than 8 cannulation attempts
  • Precut sphincterotomy
  • Endoscopic papillary balloon dilation of an intact sphincter
  • Endoscopic pancreatic duct sphincterotomy
  • Ampullectomy
  • Total bilirubin < 1.0

ii. Or possession of two or more of the following minor criteria:

  • Female sex
  • Age under 50 years
  • Personal history of recurrent acute pancreatitis
  • Pancreatic duct injection leading to "acinarization" or over 3 pancreatic duct injections
  • Pancreatic duct cytology acquisition

Exclusion criteria

  • Patients aged less than 18
  • Inability to provide informed consent
  • Pregnancy
  • Active acute pancreatitis
  • Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation < 90% on room air), chronic kidney disease (creatinine clearance < 40 mL/min), systolic congestive heart failure (ejection fraction < 45%), cirrhosis, and severe electrolyte disturbance with sodium <130 mEq/L or >150 mEq/L
  • If patient does not undergo a planned high-risk intervention
  • If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis
  • Patients with cholangitis
  • Patients with chronic and/or active pancreatitis
  • Patients with a true NSAID allergy
  • Patients greater than or equal to 75 years old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT03215862 · Pro00029546

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗