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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016771
Receipt No. R000019463
Scientific Title Clinical studies of laparoscopy endoscopy cooperative surgery for the duodenal neoplasms
Date of disclosure of the study information 2015/03/11
Last modified on 2015/03/11

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Basic information
Public title Clinical studies of laparoscopy endoscopy cooperative surgery for the duodenal neoplasms
Acronym LECS for duodenal tumor
Scientific Title Clinical studies of laparoscopy endoscopy cooperative surgery for the duodenal neoplasms
Scientific Title:Acronym LECS for duodenal tumor
Region
Japan

Condition
Condition Duodenal submucosal tumor, Duodenal cancer in situ, Duodenal adenoma
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the safety and efficacy of the laparoscopy endoscopy cooprerative surgery for the duodenal neoplasms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Complications
Key secondary outcomes operation time, intraoperative bleeding, hospital stay, pathological findings

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

Not applicable
Gender Male and Female
Key inclusion criteria Duodenal submucosal tumor
Duodenal adenoma
Duodenal cancer in situ
Key exclusion criteria Who is not suitable for general anesthesia
Who is suspected to have advanced cancer
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Tsujimoto
Organization National Defense Medical College
Division name Department of Surgery
Zip code
Address 3-2 Namiki, Tokorozawa
TEL 04-2995-1637
Email tsujihi@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Tsujimoto
Organization National Defense Medical College
Division name Department of Surgery
Zip code
Address 3-2 Namiki, Tokorozawa
TEL 04-2995-1637
Homepage URL
Email tsujihi@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization
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 防衛医科大学校病院

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 11 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 Preinitiation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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 Safty and feasibility

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2015 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019463

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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