NIPH Clinical Trials Search

JAPANESE
JRCT ID: jRCT1042250151

Registered date:23/12/2025

Comparison of Dual-bevel raptor tip needle verses Franseen needle in EUS-TA for pancreatic mass

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedpancreatic mass
Date of first enrollment01/01/2026
Target sample size220
Countries of recruitment
Study typeInterventional
Intervention(s)Patients with pancreatic masses will be randomly assigned in a 1:1 ratio to undergo endoscopic ultrasound-guided tissue acquisition (EUS-TA) using either a dual-beveled raptor tip needle or a Franseen needle, and the outcomes will be compared between the two groups.

Outcome(s)

Primary OutcomePathological diagnostic accuracy
Secondary Outcome1. Technical success rate 2. Difficulty of needle puncture 3. Procedure-related adverse events 4. Macroscopic quantity and quality of the obtained specimen 5. Histological tissue quantity 6. Histological tumor tissue quantity

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients with pancreatic masses identified on imaging studies (CT, MRI, abdominal ultrasonography, or endoscopic ultrasonography) who are scheduled to undergo endoscopic ultrasound-guided tissue acquisition (EUS-TA).
Exclude criteria1. Patients with a prior pathological diagnosis of pancreatic cancer who undergo endoscopic ultrasound-guided EUS-TA solely for the purpose of comprehensive cancer genomic profiling. 2. Inability to visualize the pancreatic mass by endoscopic ultrasonography due to anatomical reasons. 3. Lesions deemed not amenable to needle puncture based on imaging studies. 4. Bleeding tendency, defined as a prothrombin time-international normalized ratio (PT-INR) > 1.5 or a platelet count < 50000/mm3. 5. Inability to discontinue two or more antithrombotic agents. 6. Age < 18 years. 7. Pregnancy.

Related Information

Contact

Public contact
Name Toji Murabayashi
Address 1-471-2, Funae, Ise, Mie Mie Japan 516-8512
Telephone +81-596-28-2171
E-mail murabayashitoji@m2.gmobb.jp
Affiliation Ise Red Cross Hospital
Scientific contact
Name Toji Murabayashi
Address 1-471-2, Funae, Ise, Mie Mie Japan 516-8512
Telephone +81-596-28-2171
E-mail murabayashitoji@m2.gmobb.jp
Affiliation Ise Red Cross Hospital