Comparison of tissue acquisition and MOSE-based assessment of specimen adequacy in pancreatic solid masses

A Prospective Multicenter Randomized Trial Comparing a Novel Fork-Tip Fine-Needle Biopsy Device with a Standard Franseen-Tip Needle for EUS-Guided Tissue Acquisition in Solid Pancreatic Masses Using MOSE-Based Tissue Adequacy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011505

Enrollment

180

Registered

2026-01-21

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-01-27

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 : This study will include patients with pancreatic solid masses who are scheduled to undergo endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) for histopathologic diagnosis, and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged =19 years who are legally capable of providing informed consent 2. Patients with suspected solid pancreatic masses on imaging studies (CT, MRI, EUS, etc.) who are deemed to require EUS-guided fine-needle biopsy (EUS-FNB) for histopathologic diagnosis 3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, indicating eligibility for EUS-FNB 4. Patients who have received sufficient explanation of the clinical study and have voluntarily provided written informed consent 5. Patients considered capable of undergoing follow-up during the study period

Exclusion criteria

Exclusion criteria: 1. Patients considered to be at high risk of major bleeding, including: -Platelet count 1.5 that is not correctable -Inability to discontinue anticoagulant or antiplatelet therapy 2. Severe systemic infection or sepsis 3. Acute pancreatitis within the past 4 weeks 4. Inability to undergo the procedure due to gastrointestinal perforation, severe gastrointestinal obstruction, or significant gastrointestinal stricture 5. Pregnant women, or women with a high likelihood of pregnancy in whom pregnancy status cannot be confirmed prior to the procedure 6. Clinical contraindications to general anesthesia or sedated endoscopy (e.g., uncontrolled heart failure, respiratory failure, or acute cardiovascular instability) 7. Patients deemed inappropriate for study participation by the investigator due to safety concerns or ethical considerations

Design outcomes

Primary

Measure	Time frame
The proportion (%) of lesions that achieved a MOSE score of 3 or higher at least once	—

Secondary

Measure	Time frame
histologic adequacy;diagnostic accuracy;Feasibility and success rate of molecular diagnostics (NGS);Total length of macroscopically visible tissue core and distribution of MOSE scores by pass;Procedural convenience and needle maneuverability;Safety assessment	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results