Safety and efficacy comparison evaluation of newly developed domestic ERCP guide wire with imported products

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006688

Enrollment

192

Registered

2021-10-28

Start date

2022-01-24

Completion date

Unknown

Last updated

2024-03-04

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 : It is randomly assigned 1:1 to patients with native papilla requiring selective bile duct cannulation or therapeutic ERCP. After that, selective bile duct cannulation is performed usi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 19 years old or over 2) Patients who are receiving the first time ERCP for elective diagnostic or therapeutic purposes (with naive papilla)

Exclusion criteria

Exclusion criteria: 1) Patients who are judged to have difficulty accessing the nipple by endoscopy due to past surgeries such as Billroth II or Roux-en-Y anastomosis. 2) Patients who perform ERCP for pancreatic intervention. 3) Patients with duodenal stenosis. 4) Patients with acute pancreatitis. 5) Patients with severe cardiopulmonary disease. 6) Pregnant women. 7) Patients with a history of pancreatitis in the past. 8) Patients who have already been diagnosed with acute pancreatitis or chronic pancreatitis before the procedure through abdominal computed tomography or abdominal ultrasound, serum amylase, and lipase tests with past surgical history. 9) Patients with a history of precut papillotomy for cholangiopancreatic cannulation during ERCP

Design outcomes

Secondary

Measure	Time frame
Cannulation time;Complications	—

Primary

Measure	Time frame
Technical success rate of selective bile duct cannulation	—

Countries

Korea, Republic of

Contacts

Public ContactJUNEHWAN OH

HamiltonCS

promotor86@gmail.com+82-70-8766-1661

Outcome results