Franseen study
- Conditions
- Solid pancreatic massEUS-FNAD010179
- Registration Number
- JPRN-jRCTs052180062
- Lead Sponsor
- Kitano Masayuki
- Brief Summary
The rate of diagnostic accuracy of malignancy was 68.4% in the standard group and 82.9% in the Franseen group, with a significant difference. In the secondary endpoints, the sensitivity and specificity for diagnosis of malignancy were 77.5% and 96% in the conventional group and 83.8% and 96.3% in the Franseen group, respectively. The technical success rate was 99.6% in both groups.In terms of sample cellularity, the Franseen group had a significantly higher volume of tissue compared to the standard group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 523
1. Pancreatic mass lesion detected on diagnostic imaging
2. Performance status : 2 or more
3. indication for histological evaluation to predict the clinical course and to select treatment methods
4. Written consent obtained following adequate explanation of the study aims, design, and procedures.
1. Blood vessel or other tumors located between the lumen of the gastrointestinal tract and the target lesion
2. Bleeding tendency
3. Any condition expected to hinder endoscope insertion
4. Gastrointestinal reconstruction after gastrectomy
5. Serious complication involving another organ
6. Known diffuse autoimmune pancreatitis
7. Any other condition or situation determined by a study investigator to represent reason for ineligibility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of the malignancy diagnosis
- Secondary Outcome Measures
Name Time Method 1. Sensitivity and specificity for the malignancy diagnosis <br>2. Procedure completion rate<br>3. Sample cellularity<br>4. Incidence of complications