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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033687
Receipt No. R000024589
Official scientific title of the study An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/07

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Basic information
Official scientific title of the study An advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Title of the study (Brief title) An advantage of a triple-row stapler closure in DP
Region
Japan

Condition
Condition Patients who undergo distal pancreatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prove an advantage of a triple-row stapler closure in DP in comparison with hand-sewn suture.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of the incidence of post operative pancreatic fistule after distal pancreatectomy
Key secondary outcomes

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 Maneuver
Interventions/Control_1 Using a triple-row stapler closure or hand-sewn suture in distal pancreatectomy.
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 distal pancreatectomy
Key exclusion criteria 1) Younger than 20years old
2) Patients with febrile
3) No written informed consent of the patients
4) Pregnancy or insufficient contraception
5) Doubtful understanding or contractual capacity of the patient
6)Patients seems inadequate for this study by investigators
Target sample size 30

Research contact person
Name of lead principal investigator Hiromichi Kawaida MD PhD
Organization Faculty of Medicine, University of Yamanashi
Division name First Department of Surgery
Address 1110 Shimokato, Chyuo-shi, Yamanashi
TEL 055-273-7390
Email hrkawaida@yahoo.co.jp

Public contact
Name of contact person Hiromichi Kawaida
Organization Faculty of Medicine, University of Yamanashi
Division name First Department of Surgery
Address 1110 Shimokato, Chyuo-shi, Yamanashi
TEL 055-273-7390
Homepage URL
Email hrkawaida@yahoo.co.jp

Sponsor
Institute First Department of Surgery ,Faculty of Medicine, University of Yamanashi
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 08 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 12 Month 01 Day
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024589

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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