UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053908 |
|---|---|
| Receipt number | R000061540 |
| Scientific Title | Comparison Between 25-gauge and 22-gauge Franseen Needles with Taper Point Stylet for Endoscopic Ultrasound-guided Sampling of Small Solid Pancreatic Lesions of 20mm or less |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/07/29 22:32:13 |
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Basic information
Public title
Comparison Between 25-gauge and 22-gauge Franseen Needles with Taper Point Stylet for Endoscopic Ultrasound-guided Sampling of Small Solid Pancreatic Lesions of 20mm or less
Acronym
Frappuccino Trial
Scientific Title
Comparison Between 25-gauge and 22-gauge Franseen Needles with Taper Point Stylet for Endoscopic Ultrasound-guided Sampling of Small Solid Pancreatic Lesions of 20mm or less
Scientific Title:Acronym
Frappuccino Trial
Region
| Japan |
Condition
Condition
Cases in which contrast-enhanced CT/MRI/EUS shows a solid lesion of 20 mm or less in the pancreas and surgical resection is planned after histological diagnosis by EUS-FNB. However, unresectable cases of lesions smaller than 10 mm should also be included.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic performance and safety of the new 22-gauge and 25-gauge Franseen needles in solid pancreatic lesions of 20 mm or less.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic capability for lesions smaller than 20 mm.
Key secondary outcomes
Diagnostic performance for lesions less than 15 mm
Diagnostic performance for lesions larger than 15 mm and smaller than 20 mm
Diagnostic performance for small lesions of 10 mm or less.
Diagnostic performance by lesion site.
The specimen volume is assessed using a high performance microscope (BZ-X800).
The proportion of 22-gauge to 25-gauge or 25-gauge to 22-gauge needles changed during the examination and whether this adds to the diagnostic performance.
Rate of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Random allocation to 25-gauge needle and 22-gauge needle groups. Two punctures will be performed with the allocated needle, and the needle will be changed to the other needle if the rapid cytological examination (ROSE) indicates that the specimen has not been collected, or if the endoscopist judges that the specimen is insufficient by gross examination (MOSE). However, changing the needle in such situations is also done in normal practice and the number of punctures will not be increased for this study.
Interventions/Control_2
As the site of puncture (pancreatic head/uncinate and pancreatic body/tail) is considered to be a factor that may influence the tissue collection rate, the pancreatic head/uncinate and pancreatic body/tail are allocated to two groups, the 25-gauge needle group and the 22-gauge needle group, using the head/uncinate and body/tail as allocation factors.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which contrast-enhanced CT/MRI/EUS shows a solid lesion of 20 mm or less in the pancreas and surgical resection is planned after histological diagnosis by EUS-FNB. However, unresectable lesions of 10 mm or less are also included.
Patients must be at least 20 years old at the time of registration.
Patients who have not used antithrombotic drugs within one week, or who are able to withdraw or use alternative therapies.
Patients who have given written consent to participate in the study.
Key exclusion criteria
Cases in which withdrawal or substitution of antithrombotic drugs is difficult.
Patients with poorly controlled infections.
Pregnancy or possible pregnancy and lactating women.
Cases with severe mental disorders.
Cases in which tissue samples are taken in anticipation of gene panel testing.
Cases in which the principal investigator or research assistant deems the study to be unsuitable for safe conduct.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4668560
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
+81527442602
ishitaku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4668560
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
+81527442602
Homepage URL
ishitaku@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsuruma-cho, Showa-ku, Nagoya
Tel
+81527442479
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After review by the Ethics Committee, it was decided to register the study as a non-specific clinical study and to transfer it to jRCT, and it was discontinued on the UMIN-CTR(jRCT1042240063).
Management information
Registered date
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061540
