UMIN-CTR Clinical Trial

Basic information
Public title	Early Chronic Pancreatitis Findings on EUS are Associated with Pancreatic Fibrosis, Chronic Inflammation, and Atrophy
Acronym	EUS findings of Early CP and Histology
Scientific Title	Early Chronic Pancreatitis Findings on EUS are Associated with Pancreatic Fibrosis, Chronic Inflammation, and Atrophy
Scientific Title:Acronym	EUS findings of Early CP and Histology
Region	Japan

Condition
Condition	intraductal papillary mucinous neoplasm, pancreatic neuroendocrine neoplasm, pancreatic ductal carcinoma in body/tail of the pancreas, and distal cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims to elucidate the associations of between EUS findings of early CP and histology.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Our primary hypothesis testing evaluated the statistical association between EUS findings (hyperechoic foci/stranding or lobularity) and histology (pancreatic fibrosis, inflammation, or atrophy).
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients aged over 20 years 2)The clinical data of 221 patients with pancreatic tumor or distal cholangiocarcinoma who underwent preoperative EUS and pancreatic surgery from January 2010 to November 2020 were collected.
Key exclusion criteria	1)Patients who have requested not to participate in this study based on public information. 2) Patients whose pathology specimens do not contain evaluable pancreatic tissue. 3) Patients deemed inappropriate by the principal investigator.
Target sample size	221

Research contact person
Name of lead principal investigator	1st name Atsuhiro Middle name Last name Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	0783826305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Inomata
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	0783826305
Homepage URL
Email	inomat@med.kobe-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Internal Medicine Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology, Department of Internal Medicine Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Gastroenterology, Department of Internal Medicine Kobe University Graduate School of Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel	0783826305
Email	rinri@med.kobe-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	2021 Year 09 Month 16 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	221
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	No longer recruiting
Date of protocol fixation	2021 Year 09 Month 01 Day
Date of IRB	2021 Year 09 Month 22 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2021 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Clinical information included age, sex, BMI, diabetes mellitus, alcohol consumption, and smoking status (never, former, or current). Early CP EUS indings and histology of background pancreas were also collected.

Management information
Registered date	2021 Year 09 Month 16 Day
Last modified on	2021 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051640