A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
- Conditions
- solid pancreatic masses
- Registration Number
- JPRN-UMIN000032598
- Lead Sponsor
- Japanese Red Cross Wakayama Medical Center
- Brief Summary
A total of 93 patients (40.9 % female; mean age 70.1 years) underwent EUS-FNA with the novel 21-gauge needle (n = 47) or the standard 22-gauge needle (n = 46). Baseline characteristics did not differ between the groups. The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100 % in the 21-gauge group vs. 95.7% in the 22-gauge group, P = 0.242). Nevertheless, the 21-gauge needle resulted in significantly higher scores for cellularity (P = 0.010), and lower scores for blood contamination (P < 0.001). The median number of needle passes using the 21-gauge needle was less as compared to the 22-gauge needle (2 and 3, respectively, P = 0.003). The needle angle during puncture was more restricted in the 21-gauge needle (P < 0.001). Procedure-related complication rate was not different between the groups (P = 0.148).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Patients with ECOG Performance status 4 2. Patients with bleeding tendency (prothrombin time international normalized ratio >1.5, platelets <50000) 3. Patients with pancreatic mass which cannot be visualized on EUS 4. Patients younger than 20 years old 5. Patients who do not agree to participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of diagnostic yield (sample cellularity and bloodiness) of the FNA samples between newly designed 21-gauge and standard 22-gauge needles for solid pancreatic masses
- Secondary Outcome Measures
Name Time Method Comparison of technical success, diagnostic performance for malignancy, the number of needle passes required to obtain a diagnosis, needle angle during puncture, and complications