UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective observational study on the diagnostic ability and safety of an oral pancreatoscopy in the preoperative assessment of pancreatic intraductal papillary mucinous neoplasm involving the main pancreatic duct
Acronym	Observational study on the diagnostic ability and safety of an oral pancreatoscopy in the assessment of IPMN involving the main pancreatic duct
Scientific Title	Retrospective observational study on the diagnostic ability and safety of an oral pancreatoscopy in the preoperative assessment of pancreatic intraductal papillary mucinous neoplasm involving the main pancreatic duct
Scientific Title:Acronym	Observational study on the diagnostic ability and safety of an oral pancreatoscopy in the assessment of IPMN involving the main pancreatic duct
Region	Japan

Condition
Condition	Intraductal papillary mucinous neoplasm
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the diagnostic ability and safety of an oral pancreatoscopy in the preoperative assessment of intraductal papillary mucinous neoplasm involving the main pancreatic duct.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diagnostic sensitivity
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent POPS for intraductal papillary mutinous neoplasm between June 1, 2018 and March 31, 2021
Key exclusion criteria	1) Minor 2) Patients who are judged to be inappropriate for the principal investigator or coordinator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Yasuda
Organization	University of Toyama
Division name	Third Department of Internal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL	076-434-7301
Email	yasudaich@gmail.com

Public contact
Name of contact person	1st name Kosuke Middle name Last name Takahashi
Organization	University of Toyama
Division name	Third Department of Internal Medicine
Zip code	930-0194
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL	076-434-7301
Homepage URL
Email	takapochi0809@gmail.com

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	none
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	Center for Clinical Reserch in Toyama University Hospital
Address	2630 Sugitani, Toyama city, Toyama prefecture, Japan
Tel	076-415-8857
Email	rinri@adm.u-toyama.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 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	30
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 02 Month 02 Day
Date of IRB	2021 Year 02 Month 02 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 08 Month 29 Day
Last modified on	2021 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051740