MedPath

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

Not Applicable
Completed
Conditions
Diseases of the digestive system
Registration Number
KCT0006688
Lead Sponsor
Hallym University Medical Center-Dongtan
Brief Summary

The primary biliary cannulation success rates were similar in both groups (75.8% vs. 84.2%, p = 0.102), and the final cannulation success rates after rescue were also not significantly different (97.9% vs.98.9%, p = 0.500)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
192
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

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Technical success rate of selective bile duct cannulation
Secondary Outcome Measures
NameTimeMethod
Cannulation time;Complications
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