Discovery of serum proteome biomarkers and integration with pancreatitis-related gene polymorphisms for prediction of post-ERCP pancreatitis

Discovery of serum proteome biomarkers and integration with pancreatitis-related gene polymorphisms for prediction of post-ERCP pancreatitis - Biomarker study for post-ERCP pancreatitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061922

Enrollment

600

Registered

2026-06-15

Start date

2027-01-01

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 ERCP pancreatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 20 years or older who are hospitalized at Juntendo University Hospital, Nerima Hospital, or Urayasu Hospital and are scheduled to undergo or have previously undergone ERCP for the diagnosis or treatment of hepatobiliary-pancreatic diseases, and who have provided written informed consent after receiving a thorough explanation of the study

Exclusion criteria

Exclusion criteria: Patients from whom written informed consent cannot be obtained, or those deemed ineligible by the principal investigator

Design outcomes

Primary

Measure	Time frame
Identification of serum proteins significantly altered between PEP and non-PEP groups by STL/LEL lectin enrichment-LC-MS/MS analysis of pre-ERCP (approximately 24 hours before) and post-ERCP (24 hours after) sera (fold change >=2, FDR <=1%)	—

Secondary

Measure	Time frame
1.Association between single nucleotide polymorphisms of pancreatitis-related genes (PRSS1, SPINK1, CTRC, CFTR) and PEP development (assessed within 24 hours after ERCP) 2.Validation of candidate biomarker proteins identified in the Discovery phase by ELISA or selected reaction monitoring (SRM) in an independent validation cohort 3.Predictive accuracy (AUC) of an integrated PEP prediction score combining proteome data and gene polymorphism data	—

Measure

Time frame

1.Association between single nucleotide polymorphisms of pancreatitis-related genes (PRSS1, SPINK1, CTRC, CFTR) and PEP development (assessed within 24 hours after ERCP) 2.Validation of candidate biomarker proteins identified in the Discovery phase by ELISA or selected reaction monitoring (SRM) in an independent validation cohort 3.Predictive accuracy (AUC) of an integrated PEP prediction score combining proteome data and gene polymorphism data

—

Countries

Japan

Contacts

Public ContactTomoya Takahashi

Juntendo University Hospital Department of Gastroenterology

t.takahashi.cp@juntendo.ac.jp03-3813-3111

Outcome results