NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052180062

Registered date:14/02/2019

Franseen study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedSolid pancreatic mass
Date of first enrollment19/07/2018
Target sample size520
Countries of recruitment
Study typeInterventional
Intervention(s)Randomized selection of puncture needle

Outcome(s)

Primary OutcomeAccuracy of the malignancy diagnosis
Secondary Outcome1. 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
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Masahiro Itonaga
Address 811-1 Kimiidera,Wakayama City,Wakayama Wakayama Japan 641-8510
Telephone +81-73-447-2300
E-mail 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
E-mail kitano@wakayama-med.ac.jp
Affiliation Wakayama Medical University Hospital