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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003337
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Surgery, Kansai Medical University Hirakataka Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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