Biliary tract diseases requiring ERCP
Conditions
Interventions
ERCP
Sponsors
Sendai City Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patients requiring ERCP for the biliary system based on imaging and blood test findings. b. Patients with an untreated duodenal papilla, without prior sphincterotomy, papillectomy, or biliary stenting. c. Patients needing or likely to need a cholangioscope for bile duct stone treatment, biliary stricture evaluation, or cystic duct cannulation. d. Patients who provided written informed consent, personally or through a legal representative.
Exclusion criteria
Exclusion criteria: a. Patients unable to undergo endoscopic treatment due to general condition, jaw, oral, or gastrointestinal issues. b. Patients with ASA classification class 4 or higher (severe systemic disease posing a life threat) or severe comorbidities such as congestive heart failure, severe coronary insufficiency, recent myocardial infarction (within 3 months), renal failure, liver failure, bleeding peptic ulcer, paralytic ileus, bowel obstruction, or uncontrolled diabetes. c. Patients with a duodenal papilla entirely located within a periampullary diverticulum. d. Patients suspected of having a duodenal papillary tumor. e. Patients in whom access to the duodenal papilla is impossible. f. Patients with apparent invasion to the duodenal papilla by malignant tumors of the pancreatic head or surrounding area. g. Patients with surgically reconstructed upper gastrointestinal anatomy, excluding Billroth I. h. Patients who have previously undergone ERCP with endoscopic sphincterotomy or papillectomy. i. Patients with a duodenal papilla that has clearly separate openings for the bile duct and pancreatic duct. j. Patients with impacted duodenal papillary stones where part of the stone is visible at the papillary opening. k. Patients with a biliary stent in place after a prior ERCP (including inside plastic stents). l. Patients with a history of severe allergic reactions to biliary contrast agents. m. Pregnant patients or those with a possible pregnancy. n. Patients deemed unsuitable for study participation by the attending physician or affiliated department, group, or institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of bile duct cannulation within 10 minutes | — |
Countries
Japan
Contacts
Public ContactHiroaki Kusunose
Sendai City Medical Center Department of Gastroenterology
Outcome results
None listed