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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019317
Receipt No. R000022317
Scientific Title Magnetic Compression Anastomosis for Stenosis of Gastrojejunostomy
Date of disclosure of the study information 2015/10/13
Last modified on 2015/10/13

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Basic information
Public title Magnetic Compression Anastomosis for Stenosis of Gastrojejunostomy
Acronym MCA for Stenosis of Gastrojejunostomy
Scientific Title Magnetic Compression Anastomosis for Stenosis of Gastrojejunostomy
Scientific Title:Acronym MCA for Stenosis of Gastrojejunostomy
Region
Japan

Condition
Condition Stenosis of choledochojejunostomy
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of the magnetic compression anastomoisis for stenosis of choledochojejeunostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Stenosis rate (%) of the diamter of anastomisis at 6 months and 1 year
after MCA.
Key secondary outcomes The duration time (months) until the reurrence of jaudice after excretion of the magnets.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Insertion of the magnets into the site of the stenosis of the choledochojejeunostomy.
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 All following conditions of the patients should be satisfied;
1) The patient has anastomotic stenosis of choledochojejunostomy with Roux-en-Y anastomosis.
2) Double balloon endoscopy for ERBD and Rendezvous method from PTCD cathter had failed.
3) The patients is well integrated to understand the informed consent.
Key exclusion criteria The patient have malnutrition supposed to be difficult to form fistula during the magnetic compression therapy.
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hikota Hayashi
Organization Faculty of Medicine, Shimane University
Division name Department of Digestive and General Surgery
Zip code
Address Enya-cho 89-1, Izumo city, Shimane, Japan
TEL 0853-25-8253
Email hikota@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hikota Hayashi
Organization Faculty of Medicine, Shimane University
Division name Department of Digestive and General Surgery
Zip code
Address Enya-cho 89-1, Izumo city, Shimane, Japan
TEL 0853-25-8253
Homepage URL
Email hikota@med.shimane-u.ac.jp

Sponsor
Institute Department of Digestive and General Surgery, Faculty of Medicine, Shimane University
Institute
Department

Funding Source
Organization Shimane University Hostpital
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
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
2015 Year 10 Month 13 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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 16 Day
Last follow-up date
2016 Year 10 Month 30 Day
Date of closure to data entry
2016 Year 10 Month 30 Day
Date trial data considered complete
2016 Year 10 Month 30 Day
Date analysis concluded
2016 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 12 Day
Last modified on
2015 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022317

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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