Development of a dedicated test kit for early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis

Development of a dedicated test kit for early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis - Development of a dedicated test kit for post-ERCP pancreatitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056656

Enrollment

1000

Registered

2025-01-08

Start date

2024-12-27

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

Post-endoscopic retrograde cholangiopancreatography pancreatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are scheduled to undergo initial ERCP for diagnosis or treatment of biliopancreatic diseases. Cases in which the patient is 20 years of age or older and able to obtain written consent (written consent from a surrogate is also acceptable)

Exclusion criteria

Exclusion criteria: Cases of acute pancreatitis Cases of bile duct jejunal anastomosis Other cases judged to be inappropriate for participation in this study

Design outcomes

Primary

Measure	Time frame
Predictive ability of blood trypsinogen-2 for PEP at 1 hour post-ERCP: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value	—

Secondary

Measure	Time frame
Predictive ability of serum amylase for PEP at 1 hour post-ERCP Incidence rate and severity of PEP Incidence rate and severity of ERCP-related and fluid-related complications other than PEP.	—

Countries

Japan

Contacts

Public ContactRintaro Fukuda

The University of Tokyo Hospital Department of Gastroenterology

rfukuda-jun@umin.ac.jp+81-3-3815-5411

Outcome results