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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035099
Receipt No. R000039970
Official scientific title of the study Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study
Date of disclosure of the study information 2018/12/03
Last modified on 2018/12/01

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Basic information
Official scientific title of the study Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study
Title of the study (Brief title) Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study
Region
Japan

Condition
Condition cholangio-/pancreatico-jejunostomy anastomotic strictures
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of a forward-viewing echoendoscope for cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenostomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of treatment success by a forward-viewing echoendoscope for cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenostomy
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 1) a patient after modified Child's pancreatoduodenectomy
2) a patient with suspected Cholangio-/pancreatico-jejunostomy anatomic stricture
3) obtaining written informed consent
Key exclusion criteria 1) Performance Status 4
2) pregnancy
3) a patient with previous surgery for upper digestive tract, pancreas, biliary tract expect for modified Child's pancreatoduodenectomy
4) patients considered ineligible for this study
Target sample size 20

Research contact person
Name of lead principal investigator Hirotoshi Ishiwatari
Organization Shizuoka cancer center
Division name Endoscopy
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 0559895222
Email ishihiro481019@gmail.com

Public contact
Name of contact person Hirotoshi Ishiwatari
Organization Shizuoka cancer center
Division name Endoscopy
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 0559895222
Homepage URL
Email ishihiro481019@gmail.com

Sponsor
Institute Shizuoka cancer center
Institute
Department

Funding Source
Organization Shizuoka cancer center
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
2018 Year 12 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 24 Day
Anticipated trial start date
2018 Year 12 Month 03 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 none

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039970

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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