JRCT ID: jRCTs052180062
Registered date:14/02/2019
Franseen study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Solid pancreatic mass |
Date of first enrollment | 19/07/2018 |
Target sample size | 520 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Randomized selection of puncture needle |
Outcome(s)
Primary Outcome | Accuracy of the malignancy diagnosis |
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Secondary Outcome | 1. Sensitivity and specificity for the malignancy diagnosis 2. Procedure completion rate 3. Sample cellularity 4. Incidence of complications |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 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. |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Kitano Masayuki |
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Secondary Sponsor | Source of Monetary Support Secondary Sponsor : Boston Scientific Japan K.K. |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000030634 |
Contact
Public contact | |
Name | Masahiro Itonaga |
Address | 811-1 Kimiidera,Wakayama City,Wakayama Wakayama Japan 641-8510 |
Telephone | +81-73-447-2300 |
itonaga@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University Hospital |
Scientific contact | |
Name | Masayuki Kitano |
Address | 811-1 Kimiidera, Wakayama City, Wakayama Wakayama Japan 641-8510 |
Telephone | +81-73-447-2300 |
kitano@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University Hospital |