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guidewire for ERCP

Comparison of the safety and efficacy of novel domestic guidewire for ERCP comparing with conventional imported guidewire

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009650
Enrollment
190
Registered
2024-07-26
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-19

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 : Patients with native papilla who require elective biliary intubation and therapeutic ERCP will be randomly assigned 1:1. Afterwards, during ERCP, selective biliary intubation is perfo

Sponsors

Hallym University Medical Center-Dongtan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18 years or older 2) Patients undergoing ERCP for the first time for diagnostic or treatment purposes (naïve papilla: patients with intact papilla as they have never undergone ERCP)

Exclusion criteria

Exclusion criteria: 1) Patients judged to be difficult to access the papilla normally with an endoscope due to previous surgery such as Billoroth II or Roux-en-Y anastomosis 2) Patients who have already been diagnosed with acute pancreatitis within 2 weeks of the procedure when combining imaging tests such as abdominal CT and serum amylase or lipase tests 3) Patients diagnosed with chronic pancreatitis 4) When precut papillotomy was performed for selective biliopancreatic duct intubation during ERCP. 5) When ERCP is performed for pancreatic intervention or additional pancreatic intervention is performed during ERCP 6) Patients in whom ERCP is impossible due to technical difficulty in inserting a duodenoscope due to gastric outlet obstruction such as duodenal stenosis

Design outcomes

Primary

MeasureTime frame
Technically selective bile duct insertion success rate

Secondary

MeasureTime frame
Number of guide wires required for successful bile duct intubation; Time taken to successfully insert bile duct; complications

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026