UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041352 |
|---|---|
| Receipt number | R000047211 |
| Scientific Title | Usefulness of Endoscopic Ultrasound-guided Fine-needle Biopsy for the Diagnosis of Type 1 Autoimmune Pancreatitis Using a 19G Franseen needle |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2025/02/09 20:49:12 |
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Basic information
Public title
Usefulness of Endoscopic Ultrasound-guided Fine-needle Biopsy for the Diagnosis of Type 1 Autoimmune Pancreatitis Using a 19G Franseen needle
Acronym
AIP 19G Franseen Needle study
Scientific Title
Usefulness of Endoscopic Ultrasound-guided Fine-needle Biopsy for the Diagnosis of Type 1 Autoimmune Pancreatitis Using a 19G Franseen needle
Scientific Title:Acronym
AIP 19G Franseen Needle study
Region
| Japan |
Condition
Condition
Type 1 autoimmune pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of EUS-FNB using a 19G Franseen needle for the diagnosis of type 1 autoimmune pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological diagnostic accuracy of EUS-FNB using a 19G Franseen needle for type 1 autoimmune pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Using a 19G Franseen needle.
Interventions/Control_2
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
Patients who met the imaging and clinical findings based on the international consensus diagnostic criteria and require histological evaluation by EUS-FNB.
Key exclusion criteria
Not possible to suspend antithrombotic drugs
poorly controlled infection
serious drug allergy
current pregnancy or lactation, possible pregnancy, or possible intent to become pregnant
severe mental disorders
judgment of ineligibility by the principal investigator or subinvestigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
Tsuruma-cho, Showa-ku, Nagoya
TEL
0527442602
ishitaku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
Tsuruma-cho, Showa-ku, Nagoya
TEL
0527442602
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
Ethics committee of Nagoya University Hospital
Address
65, Tsuruma-cho, Showa-ku, Nagoya, 4668550
Tel
0527442479
iga-shinsa@adm.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
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38716862/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38716862/
Number of participants that the trial has enrolled
20
Results
EUS-FNB using a 19-gauge Franseen needle demonstrated favorable performance for the histological diagnosis of AIP and allowed for large tissue samples, potentially facilitating pathological diagnosis. However, during transduodenal puncture, maneuverability is reduced; therefore, the needle may need to be selected according to the puncture site.
Results date posted
| 2025 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty patients suspected of having type 1 AIP were prospectively enrolled and underwent EUS-FNB with a 19-gauge Franseen needle.
Participant flow
Their data were compared with those of historical controls: a total of 29 type 1 AIP patients had EUS-FNB with a 22-gauge Franseen needle.
Adverse events
AEs were observed in three patients (15%), and in two patients, the needles were switched to 22-gauge needles due to poor maneuverability and instrumental problems during transduodenal puncture. One patient developed mild postprocedural abdominal pain immediately after the procedure but recovered within 24 h without medication, and no patients needed prolongation of admission because of adverse events. One patient experienced pulsatile bleeding immediately after puncture, which was not defined as an AE, but the bleeding stopped spontaneously
Outcome measures
Pathological findings, especially florid fibrosis, were diagnosed based on the Guidance for Biopsy Diagnosis of AIP. Specimen volume was automatically measured using a Keyence all-in-one microscope (BZ-X800). 29 cases of type 1 AIP with 22G Francine shaped needles were compared as historical controls at our hospital before October 2022.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047211
