UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027668 |
|---|---|
| Receipt number | R000030984 |
| Scientific Title | Evaluation of the new 22-gauge EUS guided Biopsy Needle (Acqiure) Comparing to another new 20-gauge FNA needle with forward-cutting bevel (ProCore) in Patients With Autoimmune Pancreatitis : A Prospective Randomized, Controlled Multicenter Study |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/12/08 11:00:45 |
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Basic information
Public title
Evaluation of the new 22-gauge EUS guided Biopsy Needle (Acqiure) Comparing to another new 20-gauge FNA needle with forward-cutting bevel (ProCore) in Patients With Autoimmune Pancreatitis : A Prospective Randomized, Controlled Multicenter Study
Acronym
Comparing the diagnostic yield of EUS-FNA using ProCore and Acquire in patients with AIP (COMPAS study)
Scientific Title
Evaluation of the new 22-gauge EUS guided Biopsy Needle (Acqiure) Comparing to another new 20-gauge FNA needle with forward-cutting bevel (ProCore) in Patients With Autoimmune Pancreatitis : A Prospective Randomized, Controlled Multicenter Study
Scientific Title:Acronym
Comparing the diagnostic yield of EUS-FNA using ProCore and Acquire in patients with AIP (COMPAS study)
Region
| Japan |
Condition
Condition
type 1 autoimmune pancreatitis
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test the hypothesis that modification of EUS needle design has a tangible impact on tissue acquisition performance in the setting of solid lesions of the pancreas. To this end, we compared the diagnostic performance and sample adequacy of 2 EUS core needles with differing tip, bevel, and sheath designs in a large, single- center cohort of patients with solid pancreatic masses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Diagnostic yield of the 22G Acquire and the 20G ProCore needle
Key secondary outcomes
1) Diagnostic accuracy and specificity of the 22G Acquire and the 20G ProCore needle
2) Contribution of histologic findings to the diagnosis of AIP according to the ICDC
3) Diagnostic sufficiency of Tissue obtained by the EUS needles
4) Evaluation of marked lymphoplasmacytic infiltration with fibrosis and without granulocytic infiltration.
5) Evaluation of abundant (>10 cells/HPF) IgG4-positive cells
6) storiform fibrosis
7) obliterative phlebitis
8) Success rate of EUS-FNA
9) Rate of complications related with EUS-FNA. the EUS needles
10) Comparing diagnostic accuracy of 1st pass and total passes in two groups, respectively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Acquire needle
Interventions/Control_2
ProCore needle
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 with suspect of type 1 autoimmune pancreatitis
Agree to consent form
Patients with ECOG performance status 0 or 1
Key exclusion criteria
1) Uncorrectable coagulopathy (INR > 1.5). Or uncorrectable thrombocytopenia (platelet < 50,000)
2) Uncooperative patients
3) Inaccessible lesions to EUS
4) Patients with ASA criteria 3, 4, or 5
5) Refusal to consent form
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | AKira |
| Middle name | |
| Last name | Kurita |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Division of Gastroenterology and Hepatology, Digestive Disease Center
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL
06-6131-2662
kuritaaki1976@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kurita |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Division of Gastroenterology and Hepatology, Digestive Disease Center
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL
06-6131-2662
Homepage URL
kuritaaki1976@gmail.com
Sponsor or person
Institute
Bilio-Pancreatic Stenting study group
Institute
Department
Personal name
Funding Source
Organization
None
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
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
Tel
06-6131-2662
rinshou@kitano-hp.or.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
大阪医科大学附属病院（大阪府）、関西医科大学附属病院(大阪府)、大阪市立大学医学部附属病院（大阪府）、近畿大学医学部附属病院（大阪府）、北野病院（大阪府)、大阪赤十字病院（大阪府）、天理よろづ相談所病院（奈良県）、神戸大学医学部附属病院（兵庫県）、川崎医科大学附属総合医療センター（岡山県）、福岡大学筑紫病院（福岡県）、宮崎大学医学部附属病院（宮崎県)、熊本大学医学部附属病院（熊本県）、和歌山県立医科大学附属病院（和歌山県）、京都大学医学部附属病院（京都府）、鹿児島大学医学部附属病院（鹿児島県）、大阪国際がんセンター（大阪府）、鳥取赤十字病院（鳥取県）、北播磨総合医療センター（兵庫県）、島根大学医学部附属病院（島根県）、京都桂病院（京都ふ）、京都府立医科大学附属病院（京都府）、広島赤十字・原爆病院（広島県）、久留米大学医学部附属病院（福岡県）、淀川キリスト教病院（大阪府）、済生会中津病院（大阪府）、香川大学医学部附属病院（香川県）、鳥取大学医学部附属病院（鳥取県）、ベルランド総合病院（大阪府）、大阪大学医学部附属病院（大阪府）、大阪市立総合医療センター（大阪府）、JA尾道総合病院（広島県）、日赤和歌山医療センター（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
110
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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030984
