Diseases requiring ERCP. Bile duct stones, papillary dysfunction, biliary tract cancer, pancreatic cancer, IPMN, etc.
Conditions
Interventions
For infusions from 8 hours before ERCP to the start of ERCP, any type of infusion is acceptable.
It should be administered at a rate not exceeding 1.5 ml/kg/h.
Normal infusion group: Ringer's solutio
Post-ERCP pancreatitis, Loading infusion
Sponsors
Yamada Reiko
Nakagawa Hayato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria must be met in order to participate in this study. 1)Patients over 18 years old. 2)Patients who have provided written consent to participate in the study. 3)Patients requiring examination or treatment by ERCP.
Exclusion criteria
Exclusion criteria: Patient who meet any of the following criteria may not participate in this study. 1) Patients who have previously undergone ERCP and have a history of EST or EPBD for major duodenal papilla. 2) Patients with any one of the following criteria 1-3 regarding cardiac function. 1 New York Heart Association (NYHA) cardiac function classification of grade II or higher. 2 Left ventricular ejection fraction 100 pg/ml or serum NT-proBNP > 400 pg/ml. 3) Patients with renal dysfunction (eGFR147 mEq/L). 8) Patients with ECOG PS (Eastern Cooperative Oncology Group Performance Status) >2. 9) Patients who cannot receive diclofenac sodium intrarectally due to colostomy. 10) Patients for whom diclofenac sodium is contraindicated. 11) Patients with a history of allergy to iodine contrast media. 12) Patient with surgical altered anatomy. 13) Patients who are unable to reach the major duodenal papilla by endoscope due to stenosis of the digestive tract. 14) Patients who are initially scheduled for transpapillary intubation into the biliary or pancreatic ducts with guidewire-assisted insertion via the PTBD puncture route (rendezvous under PTBD) or with guidewire-assisted insertion via the EUS puncture route (rendezvous under EUS). 15) Pregnant or possibly pregnant patients. 16) Patients deemed inappropriate for inclusion in the study by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of PEP | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of PEP by severity. Incidence rate of hyperamylasemia. Incidence of adverse events associated with infusion. | — |
Contacts
Public ContactKenji Nose
Department of Gastroenterology and Hepatology, Mie University Graduate School of Medicine, Tsu, Japan
Outcome results
None listed