A study on the effectiveness of a novel preservative fluid (CytoRich Red) for diagnosing pancreatic tumor using endoscopic ultrasound

A single-center prospective observational study evaluating the diagnostic yield of endoscopic ultrasound-guided tissue acquisition (EUS-TA) using BD CytoRich Red preservative fluid for pancreatic tumor - CytoRich Red EUS-TA Pancreatic Tumor Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059162

Enrollment

110

Registered

2025-09-22

Start date

2025-04-05

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

pancreatic tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing endoscopic ultrasound-guided tissue acquisition (EUS-TA) for pancreatic tumors at our hospital between April 2025 and March 2028 Patients who provide written informed consent to participate in the study after receiving an adequate explanation and fully understanding the details

Exclusion criteria

Exclusion criteria: Patients who are medically ineligible for EUS-TA Patients deemed inappropriate for participation in this study by the principal investigator or co-investigators

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, and accuracy of rapid on-site evaluation (ROSE)	—

Secondary

Measure	Time frame
Diagnostic yield of EUS-TA (Sensitivity, specificity, and accuracy based on histological and final cytological diagnoses) Technical success rate of EUS-TA procedures Incidence rate of adverse events (percentage of patients experiencing complications related to EUS-TA), details, and severity of adverse events Proportion of samples successfully analyzed by next-generation sequencing (NGS) among specimens submitted for analysis Proportion of tumor cells within collected samples Detailed genomic alterations identified in successfully analyzed cases Proportion of patients receiving targeted therapies matched to detected genomic alterations Comparative evaluation of diagnostic yield and NGS success rate according to the type of needle used	—

Measure

Time frame

Diagnostic yield of EUS-TA (Sensitivity, specificity, and accuracy based on histological and final cytological diagnoses) Technical success rate of EUS-TA procedures Incidence rate of adverse events (percentage of patients experiencing complications related to EUS-TA), details, and severity of adverse events Proportion of samples successfully analyzed by next-generation sequencing (NGS) among specimens submitted for analysis Proportion of tumor cells within collected samples Detailed genomic alterations identified in successfully analyzed cases Proportion of patients receiving targeted therapies matched to detected genomic alterations Comparative evaluation of diagnostic yield and NGS success rate according to the type of needle used

—

Countries

Japan

Contacts

Public ContactHidenobu Hara

Yokohama City Minato Red Cross Hospital Gastroenterology

hidenobu1005_0406@yahoo.co.jp0456286100

Outcome results