UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography
Title of the study (Brief title)	Minimal Ascites by EUS in Pancreatic Cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether or not minimal ascites in preoperative assessment by EUS is prognostic factor for patients with pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of the prognosis in patients with pancreatic cancer with or without minimal asicites in preoperaitve assessment by EUS
Key secondary outcomes	1 Detection rate of minimal ascites by EUS 2 Comparison of the detectability of minimal asictes by EUS and other image modarities. 3 Comparison of the prognosis in pancreatic cancer with minimal asictes in preoperative assessment of EUS and malignant cells in peritoneal cytology

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patinets with pancreatic cancer who underwent the preoperative assessment by EUS and surgical resection. Patinets with written informed consent.
Key exclusion criteria	Patients with ascites caused by other than panceatic cancer. Patinets without written infromed consent. Patinets considered ineligible for this study.
Target sample size	120

Research contact person
Name of lead principal investigator	Rintaro Mikata
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Address	1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL	81-43-222-7171
Email	mikata@faculty.chiba-u.jp

Public contact
Name of contact person	Rintaro Mikata
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Address	1-8-1 Inohana, Chuo Ward, Chiba 260-8670, Japan
TEL	81-43-222-7171
Homepage URL
Email	mikata@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Chiba University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 08 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 28 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Nothing paticular

Management information
Registered date	2017 Year 08 Month 08 Day
Last modified on	2017 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032652