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) studied | pancreatic mass |
| Date of first enrollment | 01/01/2026 |
| Target sample size | 220 |
| Countries of recruitment | |
| Study type | Interventional |
| 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 Outcome | Pathological diagnostic accuracy |
|---|---|
| Secondary Outcome | 1. 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 maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients 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 criteria | 1. 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
| Primary Sponsor | Murabayashi Toji |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Toji Murabayashi |
| Address | 1-471-2, Funae, Ise, Mie Mie Japan 516-8512 |
| Telephone | +81-596-28-2171 |
| 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 |
| murabayashitoji@m2.gmobb.jp | |
| Affiliation | Ise Red Cross Hospital |