None listed
Conditions
Interventions
None listed
Sponsors
Inha University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) the provision of written informed consent and an age between 18 and 90 years, (2) a naïve ampulla (no previous procedure performed), (3) suspected to have biliary obstruction or biliary disease, (4) need for ERCP for the treatment of biliary obstruction, and (5) risk of PEP defined as at least one of the following: suspected biliary sphincter of Oddi dysfunction (SOD), an age between 18 and 50 years, female, normal common bile duct diameter (= 9 mm), normal serum bilirubin level, an obese status (body mass index > 30), or a history of acute pancreatitis.
Exclusion criteria
Exclusion criteria: (1) an age of < 18 years, (2) pregnant, (3) mental retardation, (4) sensitivity to contrast agents, (5) a history of sphincterotomy or a pancreatobiliary procedure, (6) ampulla of Vater cancer (7) a difficult ampulla approach due to abdominal surgery including stomach cancer with Billroth II anastomosis, or (8) one or more of the following pancreatic diseases: acute pancreatitis within 30 days prior to enrollment, idiopathic acute recurrent pancreatitis, pancreatic divisum, obstructive chronic pancreatitis, pancreatic cancer, or (9) peri-ampullary diverticulum type I or II.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of pancreatitis | — |
Secondary
| Measure | Time frame |
|---|---|
| successful rate of cannulation;the successful rate of treatment of biliary obstruction;The adverse event related with procedure | — |
Countries
Korea, Republic of
Contacts
Public ContactJIn-Seok Park
Inha University Hospital
Outcome results
None listed