UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023311 |
|---|---|
| Receipt number | R000026773 |
| Scientific Title | Randomized control study of the usability of vessel sealing devices at the time of pancreatoduodenectomy |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2021/01/31 19:16:26 |
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Basic information
Public title
Randomized control study of the usability of vessel sealing devices at the time of pancreatoduodenectomy
Acronym
Randomized control study of the usability of vessel sealing devices at the time of pancreatoduodenectomy
Scientific Title
Randomized control study of the usability of vessel sealing devices at the time of pancreatoduodenectomy
Scientific Title:Acronym
Randomized control study of the usability of vessel sealing devices at the time of pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Diseases which required pancreas head resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Some reports advocated the valuable usability of surgical energy devices to reduce operative time and blood loss. However there were no comparative analysis of surgical energy devises. Therefore we have planed a randomized controlled study of surgical energy devices to evaluate its usability and safeness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Subjective evaluation of sealing devices by surgeon (questionnaire survey)
Key secondary outcomes
1.Operative time and intra-operative blood loss
2.Postoperative complications
3.Quantity of drainaged fluid at postoperative day 1 and 2.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LigaSure Small Jaw produced by COVIDIEN JAPAN
Intervention during operation time of pancreatoduodenectomy
Interventions/Control_2
Harmonic FOCUS produced by Johnson and Johnson
Intervention during operation time of pancreatoduodenectomy
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 20 years old or more at the time of agreement of participation for this study.
#2 Patients who understood well about this study and agreed to the participation for this study.
Key exclusion criteria
#1Unresectable cases after registration to this study
#2patients who have liver cirrhosis
#3Patients who required anti coagulation therapy during perioperative time.
#4patients who was considered as inadequate by principal researcher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sohei |
| Middle name | |
| Last name | Satoi |
Organization
Kansai Medical University
Division name
Surgery
Zip code
5731010
Address
2-5-1 SHinmachi, Hirakata city, Osaka 573-1010 Japan
TEL
0728041010
satoi@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Sohei |
| Middle name | |
| Last name | Satoi |
Organization
Kansai Medical University
Division name
Surgery
Zip code
5731010
Address
2-5-1 SHinmachi, Hirakata city, Osaka 573-1010 Japan
TEL
0728041010
Homepage URL
satoi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
Shinmachi2-5-1,HirakataOsaka city, Osaka
Tel
0728041010
satoi@hirakata.kmu.ac.jp
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
| 2016 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
100
Results
unpublished
Results date posted
| 2021 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
unpublished
Participant flow
unpublished
Adverse events
unpublished
Outcome measures
unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026773
| 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 |
