Biliary-pancreatic diseases for which ERCP is indicated Choledocholithiasis, acute cholangitis, acute cholecystitis, cholangiocarcinoma, primary sclerosing cholangitis, IgG4-related sclerosing cholangitis, pancreatic cancer, autoimmune pancreatitis, pancreatic duct stricture, cystic pancreatic tumor
Conditions
Interventions
The effective initial treatment for acute pancreatitis is infusion therapy with extracellular fluid such as lactated Ringer's from the viewpoint of maintaining pancreatic microcirculation during infla
Post-ERCP pancreatitis, infusion
Sponsors
Kurita Yusuke
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-ERCP pancreatitis incidence: efficacy endpoint 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
| Measure | Time frame |
|---|---|
| 1) Severity evaluation by Cotton classificationSeverity endpoint Mild: Clinical symptoms of acute pancreatitis, and amylase at least 3 times normal after 24 hours of procedure, requiring emergency hospitalization, or extended hospitalization for 2-3 days Moderate: Hospitalization for 4-10 days Severe cases requiring: 10 days or more hospitalization, necrosis or pseudocyst formation, or percutaneous drainage or surgery required2-1) Severity evaluation based on pancreatitis clinical practice guidelines Severe pancreatitis Judgment items: Prognostic factors (described below) 3 points or more or contrast CT Grade 2 points or more2-2) Post-ERCP pancreatitis CT Grade (evaluation of pancreatitis severity by CT): Efficacy endpointCT Grade classification by contrast-enhanced CT; Evaluate the extent of inflammation outside the pancreas and the area of poor contrast of the pancreas as follows.3) Severity assessment by Atlanta classification: efficacy endpointFor the following, follow-up including late complications will be performed for at least 30 days after ERCP. Presence or absence of other complications (pancreatitis after late ERCP, bleeding, renal disorder, heart failure, etc.)Length of hospitalization. Examination of relevance to other factors (With or without NSAIDs, with or without pancreatic stent placement, with or without history of pancreatitis, with or without ERCP, with or without EST, with or without precut, with or without pancreatography, papillary dysfunction, with nipple resection, with trainees, gender, age, between institutions, etc.) | — |
Contacts
Public ContactYusuke Kurita
Yokohama City University
Outcome results
None listed