Frequency of adverse event of endoscopic sphincterotomy or endoscopic papillary balloon dilatation for naive papilla in hemodialysis patients with common bile duct stones (A multicenter prospective study)

Frequency of adverse event of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD) for naive papilla in hemodialysis patients with common bile duct stones (A multicenter prospective study) - A multicenter prospective study of adverse event rate of EST/EPBD in hemodialysis patients with common bile duct stones

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053055

Enrollment

Registered

2023-12-11

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maintenance hemodialysis patients with naive papilla and with common bile duct stones

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with untreated papilla (patients without previous EST or EPBD) Patients over 18 years-old at the time of entry Patients who have provided written consent for participation

Exclusion criteria

Exclusion criteria: Patients who have undergone EST or EPBD. Patients who cannot switch to Nafamostat as the anticoagulant for hemodialysis fluid. Patients judged by study investigator/subinvestigators as inappropriate ones

Design outcomes

Primary

Measure	Time frame
The frequency and severity of bleeding and pancreatitis post procedure in whole hemodialysis patients with common bile duct stones	—

Secondary

Measure	Time frame
1.The frequency and severity of bleeding and pancreatitis post procedure in hemodialysis patients with common bile duct stones performing EST or with EPBD, respectively 2.The frequency and severity of ERCP-related adverse events other than bleeding and pancreatitis post procedure in whole hemodialysis patients with common bile duct stones 3.The factors associated with bleeding in maintenance hemodialysis patients 4. The factors associated with pancreatitis post procedure in maintenance hemodialysis patients	—

Measure

Time frame

1.The frequency and severity of bleeding and pancreatitis post procedure in hemodialysis patients with common bile duct stones performing EST or with EPBD, respectively 2.The frequency and severity of ERCP-related adverse events other than bleeding and pancreatitis post procedure in whole hemodialysis patients with common bile duct stones 3.The factors associated with bleeding in maintenance hemodialysis patients 4. The factors associated with pancreatitis post procedure in maintenance hemodialysis patients

—

Countries

Japan

Contacts

Public ContactTeppei Yoshioka

Osaka University Graduate School of medicine Gastroenterology and Hepatology

m-shigekawa@gh.med.osaka-u.ac.jp0668793621

Outcome results