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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003895
Receipt No. R000004687
Scientific Title The study concerning about the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Date of disclosure of the study information 2010/07/09
Last modified on 2012/11/20

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Basic information
Public title The study concerning about the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Acronym The study concerning about the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Scientific Title The study concerning about the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Scientific Title:Acronym The study concerning about the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Region
Japan

Condition
Condition chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Basic objectives2 Others
Basic objectives -Others To confirm the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The estimation of the morphological change and the function of the small intestine and nutritional status in choronic pancreatitis.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 capsule endoscopy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria The study is designed to enroll patients with chronic pancreatitis.Other eligibility criteria,includes good performance status,malnutrition(%UBW is less than 95%).Written informed consent is required form all patients.
Key exclusion criteria Severe malnutritional status
Poor performance status.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65Tsuruma-Cho,Showa-Ku,Nagoya,Japan
TEL 052-741-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Nakamura
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65Tsuruma-Cho,Showa-Ku,Nagoya,Japan
TEL 052-741-2602
Homepage URL http://www.med.nagoya-u.ac.jp/hospital
Email y-naka@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Hospital
Organization
Division
Category of Funding Organization
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
2010 Year 07 Month 09 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
Up to now 8 cases included in the study.We're analyzing these data now.
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 Completed
Date of protocol fixation
2010 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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

Management information
Registered date
2010 Year 07 Month 08 Day
Last modified on
2012 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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