UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016771 |
|---|---|
| Receipt number | 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 08:21:07 |
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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
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
tsujihi@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019463
