UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019317 |
|---|---|
| Receipt number | 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 21:05:17 |
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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
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
hikota@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Digestive and General Surgery, Faculty of Medicine, Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022317
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
