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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014956
Receipt No. R000017403
Scientific Title Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Date of disclosure of the study information 2014/09/01
Last modified on 2018/03/06

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Basic information
Public title Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Acronym Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Scientific Title Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Scientific Title:Acronym Prospective cohort study of laparoscopic pancreaticoduodenectomy.
Region
Japan

Condition
Condition Patients who need pancreaticoduodenectomy
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify the relevance of patient background and the frequency of postoperative complications or patient QOL, who underwent laparoscopic pancreaticoduodenectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Postoperative complications
Key secondary outcomes Length of ostoperative hospital stay

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >
Gender Male and Female
Key inclusion criteria Younger than 80 years old and older than 20 years old at current study registration
Performance status 0 or 1
Diagnosed to need pancreatoduodenectomy by image before an operation
No lymph node metastasis or distant metastasis by image
A participant receives enough
Key exclusion criteria Presence the past history of epigastric region open surgery
Presence the past history of COPD or myocardial infarction
Cancellation of the anticoagulant is impossible
During the pregnancy or the nursing
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikara Kunisaki
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuta Minami
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email minayuu@zd6.so-net.ne.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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

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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 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 Completed
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 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 Single center prospective cohort study to evaluate the presence of complications to need the treatment that occurred within three years after laparoscopic pancreatoduodenectomy

Management information
Registered date
2014 Year 08 Month 26 Day
Last modified on
2018 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017403

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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