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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011316
Receipt No. R000013262
Scientific Title Laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy
Date of disclosure of the study information 2013/08/05
Last modified on 2014/01/30

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Basic information
Public title Laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy
Acronym Laparoscopic pancreaticoduodenectomy
Scientific Title Laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy
Scientific Title:Acronym Laparoscopic pancreaticoduodenectomy
Region
Japan

Condition
Condition Periampullary tumor, chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safty and efficacy of laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy for periampullary tumors and chronic pancreatitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safty and efficacy
Key secondary outcomes Surgical curability for tumors

Base
Study type

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Surgery
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Periampullary tumors without lymph node metastasis and invasion of vessels such as portal vein, and limited chronic pancreatitis in the pancreatic head
Key exclusion criteria 1. Tumors with lymph node metastasis and invasion of portal vein and/or nerves around superior mesenteric artery
2. Bad general condition
3. Pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Ohta
Organization Oita University Faculty of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1 Idaigaoka, Hasama-machi, Yufu, Oita 8795593, Japan
TEL 097-586-5843
Email ohta@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Ohta
Organization Oita University Faculty of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1 Idaigaoka, Hasama-machi, Yufu, Oita 8795593, Japan
TEL 097-586-5843
Homepage URL
Email ohta@oita-u.ac.jp

Sponsor
Institute Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization Other
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 大分大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 05 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 Enrolling by invitation
Date of protocol fixation
2013 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 05 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 30 Day
Last modified on
2014 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013262

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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