UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010426 |
|---|---|
| Receipt number | R000012193 |
| Scientific Title | Evaluation of efficacy and safety of tissue adhesive sheet for preventing postoperative pancreatic fistula after distal pancreatectomy |
| Date of disclosure of the study information | 2013/04/05 |
| Last modified on | 2014/10/06 07:23:31 |
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Basic information
Public title
Evaluation of efficacy and safety of tissue adhesive sheet for preventing postoperative pancreatic fistula after distal pancreatectomy
Acronym
Evaluation of efficacy of tissue adhesive sheet for preventing postoperative pancreatic fistula after distal pancreatectomy
Scientific Title
Evaluation of efficacy and safety of tissue adhesive sheet for preventing postoperative pancreatic fistula after distal pancreatectomy
Scientific Title:Acronym
Evaluation of efficacy of tissue adhesive sheet for preventing postoperative pancreatic fistula after distal pancreatectomy
Region
| Japan |
Condition
Condition
Pancreaatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an effect of prevention of pancreatic fistula by using a tissue adhesive sheet for the pancreatic stump after distal pancreatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and severity of postoperative pancreatic fistula and amylase concentration in drainage tube
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who are used tissue adhesive sheet for the stump of pancreas after distal pancreatectomy
Interventions/Control_2
Patients who are not used tissue adhesive sheet for the stump of pancreas after distal pancreatectomy
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
Patients who undergo distal pancreatectomy
Key exclusion criteria
Patients who don't meet the above criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryutaro Mori |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2650
ryutaromori@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryutaro Mori |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Research ethics committee
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2650
Homepage URL
ryutaromori@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
scholarship donation (undicided)
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 04 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 09 | 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
| 2013 | Year | 04 | Month | 05 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012193
