UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018486 |
|---|---|
| Receipt number | R000021403 |
| Scientific Title | Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2019/02/25 14:09:48 |
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Basic information
Public title
Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer
Acronym
Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer
Scientific Title
Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer
Scientific Title:Acronym
Phase II trial in treatment of gastrointestinal fistulas with endoscopic injection of an alpha-cyanoacrylate monomer
Region
| Japan |
Condition
Condition
Gastrointetinal fistulas
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the safety and efficacy of the endoscopic injection of an alpha-cyanoacrylate monomer for gastrointestinal fistulas.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of postprocedural complication
Key secondary outcomes
Incidence of fistulas closure
Postoperative course
Late complications
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Endoscopic injection of an alpha-cyanoacrylate monomer
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with intractable gastrointestinal fistulas
2) No severe disturbance of liver function and renal function
3) Written informed consent
Key exclusion criteria
1) Patients with esophagotracheal fistulas
2) Patients with bile duct fistulas
3) Patients with pancreatic duct fistulas
4) Doctor's decision not to register to this regimen
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University, School of Medicine
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
和歌山県立医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30211297
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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021403
