UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028568
Receipt No. R000032652
Scientific Title Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography
Date of disclosure of the study information 2017/08/08
Last modified on 2017/08/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography
Acronym Minimal Ascites by EUS in Pancreatic Cancer
Scientific Title Prognosis of pancreatic cancer with minimal Ascites in preoperative assessment by Endoscopic Ultrasonography
Scientific Title:Acronym 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
1st name
Middle name
Last name Rintaro Mikata
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
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
1st name
Middle name
Last name Rintaro Mikata
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.