UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003337 |
|---|---|
| Receipt number | R000004044 |
| Scientific Title | Clinical use of ultrasonic dissector in (pylorus preserving) pancreaticouodenectomy |
| Date of disclosure of the study information | 2010/03/15 |
| Last modified on | 2013/03/16 09:35:43 |
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Basic information
Public title
Clinical use of ultrasonic dissector in (pylorus preserving) pancreaticouodenectomy
Acronym
Clinical use of ultrasonic dissector in pancreaticoduodenectomy
Scientific Title
Clinical use of ultrasonic dissector in (pylorus preserving) pancreaticouodenectomy
Scientific Title:Acronym
Clinical use of ultrasonic dissector in pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Periampullary disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore whether can use of ultrasonic dissector be associated with reduction of frequency of surgical site infection, extent of blood loss, operative duration and medical cost.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Frequency of surgical site infection
Key secondary outcomes
Amount of drained fluid
Operative duration
Extent of blood loss
Counting number and price of sutures
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
| Device,equipment |
Interventions/Control_1
To perform pancreaticoduodenectomy with dissection, coagulation, and cut using ultrasonic dissector
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have the planned pancreaticoduodenectomy
Key exclusion criteria
1)younger than 20 years old or older than 90 years old.
2)Patients with febrile
3)No written informed consent of the patients
4)Pregnancy or insufficient contraception
5)HIV infection
6)Doubtful understanding or contractual capacity of the patient
7)Patients seems inadequate for this study by investigator(s)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI M.D. |
Organization
Kansai Medical University, Hirakata hospital
Division name
Department of surgery
Zip code
Address
2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI M.D. |
Organization
Kansai Medical University, Hirakata hospital
Division name
Department of surgery
Zip code
Address
2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Surgery, Kansai Medical University Hirakataka Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
関西医科大学附属枚方病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | 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
| 2010 | Year | 03 | Month | 15 | Day |
Last modified on
| 2013 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004044
