Safety and efficacy of newly developed a guidewire for ERCP: a multicenter non-inferiority trial

Safety and efficacy of a newly developed 0.025 inch guidewire with enhanced corewire for ERCP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005696

Enrollment

380

Registered

2020-12-23

Start date

2021-03-15

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Patients with native papilla requiring diagnostic or therapeutic ERCP will be randomly assigned 1: 1. Then, during ERCP, selective bile duct cannulation is performe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age =19 years, < 80 years 2) Patients with naïve papilla needed diagnostic or therapeutic ERCP

Exclusion criteria

Exclusion criteria: 1) Diagnosed acute or chronic pancreatitis before ERCP 2) Endoscopic papillectomy 3) Allergy to contrast 4) Previous history of pancreatitis 5) Inaccessable papilla due to altered anatomy

Design outcomes

Primary

Measure	Time frame
Technical success rate for selective biliary access	—

Secondary

Measure	Time frame
Cannulation time;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactTAE HOON LEE

Soon Chun Hyang University Hospital Cheonan

taewoolee9@gmail.com+82-41-570-3662

Outcome results