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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013282
Receipt No. R000015488
Scientific Title Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Date of disclosure of the study information 2014/02/26
Last modified on 2019/03/12

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Basic information
Public title Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Acronym Laparoscopy-assisted pancreatoduodenectomy
Scientific Title Laparoscopy-assisted (pylorus preserved) pancreatoduodenectomy for reduction of surgical invasiveness
Scientific Title:Acronym Laparoscopy-assisted pancreatoduodenectomy
Region
Japan

Condition
Condition The patient who receives pancreatoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Reducing of surgical invasiveness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient satisfaction
Evaluation of the patient satisfaction by a patient questionnaire
Key secondary outcomes Incidence rate of postoperative complications
Postoperative hospitalization days

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patients with periampullary lesions who will be treated until 1/31/2017
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients 20years old over(At the time of hospitalization)
2.Patients with periampullary lesions who will be treated.
3.Patients who have been informed and have understood the full explanation of this study, and have agreed and given prior written consent.
Key exclusion criteria 1.Less than 20 years old
2.The cancer patient who accepts lymph node metastases by diagnostic imaging in preoperation
3.The patient whom it is judged to need blood vessel merger excision by video diagnosis in preoperation
4.The patient who is judged to be inappropriate by the examination medical attendant
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Eguchi
Organization Nagasaki University Hospital
Division name Department of Surgery
Zip code
Address 1-7-1 Sakamoto,Nagasaki,JAPAN
TEL 095-819-7316
Email sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Amane Kitasato
Organization Nagasaki University Hospital
Division name Department of Surgery
Zip code
Address 1-7-1 Sakamoto,Nagasaki,JAPAN
TEL 095-819-7316
Homepage URL
Email kitasato@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 26 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 01 Month 29 Day
Date of IRB
2014 Year 04 Month 28 Day
Anticipated trial start date
2014 Year 04 Month 29 Day
Last follow-up date
2017 Year 01 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
2014 Year 02 Month 26 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015488

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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