UMIN-CTR Clinical Trial

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
Email	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
Email	kuritaaki1976@gmail.com

Sponsor
Institute	Bilio-Pancreatic Stenting study group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030984