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Clinical Trials/jRCTs031200202
jRCTs031200202RecruitingNot Applicable

Examination of post-ERCP pancreatitis preventive effect of load infusion therapy with lactated Ringer's solution Randomized controlled trial

Not provided0 sites950 target enrollmentStarted: March 25, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
950
Primary Endpoint
Post-ERCP pancreatitis incidence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Prevention Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
20age old over to 85age old under (—)
Sex
All

Inclusion Criteria

  • •(1) Patients aged 20 to 85 at the time of consent acquisition
  • •(2) Gender: Any
  • •(3) Patients who are clinically indicated for ERCP and undergo ERCP (malignant biliary stricture, pancreatic cancer, acute cholangitis, common bile duct stone, IgG4 sclerosing cholangitis, primary sclerosing cholangitis, etc.)
  • •(4) Post-ERCP pancreatitis risk (moderate or higher)
  • •(5) PS is 2 or less
  • •(6) Patients who can take oral drugs, meals and beverages
  • •(7) Patients expected to have stable primary disease (including cancer) 6 months after registration during the observation period
  • •(8) Patients who have written informed consent to participate in this study, who comply with the compliance items during this study participation, who can receive the medical examination prescribed in this study plan and report symptoms etc.

Exclusion Criteria

  • •(1) Patients with low risk of post-ERCP pancreatitis (confirmed cases of chronic pancreatitis, pancreatic head tumor, periodic biliary stent replacement)
  • •(2) Patients with acute pancreatitis
  • •(3) Patients with hypotension including sepsis
  • •(4) Heart failure patients (NYHA Class II or above)
  • •(5) Patients with renal failure (creatinine clearance <30 mL/min)
  • •(6) Patients with liver failure (patients with cirrhosis and ascites)
  • •(7) Patients with respiratory failure (defined as oxygen saturation <90%)
  • •(8) Hyponatremia (Na+ levels <130mEq/L)
  • •(9) Hypernatremia (Na+ levels> 150mEq/L)
  • •(10) Hypokalemia (K+ levels <3.0mEq/L)
  • •(11) Patients who are pregnant or breastfeeding, patients who wish to become pregnant during the study period, patients who wish to become pregnant of a partner during the study period.
  • •(12) In addition, patients who are judged to be unsuitable for study participation by the investigator or investigator based on combination therapy and medical findings.
  • •(13) Patients in other clinical studies or clinical trials

Outcomes

Primary Outcomes

Post-ERCP pancreatitis incidence

Time Frame: within 24 hours after ERCP

This study examines the post-ERCP pancreatitis preventive effect of fluid loading. Therefore, the primary evaluation item this time is the post-ERCP pancreatitis incidence rate as a direct evaluation item. **Diagnostic criteria for post-ERCP pancreatitis** (1) Newly developed upper abdominal pain (2) Pancreatic enzymes (amylase and/or lipase) increased more than 3 times the institutional upper limit of normal (3) (1) and (2) within 24 hours after ERCP (4) Hospitalization extension of 2 nights or more Post-ERCP pancreatitis if all of the above are met

Secondary Outcomes

  • Severity evaluation by Cotton classification
  • Severity evaluation based on pancreatitis clinical practice guidelines
  • Post-ERCP pancreatitis CT Grade
  • Severity assessment by Atlanta classification(at least 30 days after ERCP)

Investigators

Sponsor
Not provided

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