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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026726
Receipt No. R000030683
Scientific Title Feasibility study of the LECS(Laparoscopy and Endoscopy Cooperative Surgery) to the non-ampullary duodenal tumor.
Date of disclosure of the study information 2017/06/01
Last modified on 2019/03/30

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Basic information
Public title Feasibility study of the LECS(Laparoscopy and Endoscopy Cooperative Surgery) to the non-ampullary duodenal tumor.
Acronym LECS to the non-amupullary duodenal tumor
Scientific Title Feasibility study of the LECS(Laparoscopy and Endoscopy Cooperative Surgery) to the non-ampullary duodenal tumor.
Scientific Title:Acronym LECS to the non-amupullary duodenal tumor
Region
Japan

Condition
Condition non-ampullary duodenal tumor
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We assume LECS to the non-amupurally tumor is safe and effective procedure. This study aimed the verification of this.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes Complication rate(post operative bleeding,dysraphia,abscess,digestive tract disoder,re-operation rate)
Key secondary outcomes Operation time, hospitalization, pathological assessment of resected lesion

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 LECS to the non-ampullary tumor
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 non-amupullary adenoma or mucosal cancer, Neuroendocrine tumor, GIST
1.Satisfy the either of the following conditions Adenoma or adenoarcinoma
2.Tumor size 20-35mm
3.Impossible to perform endoscopic resection due to the ulceration scar
4.If cancer, limited to mucosal cancer
GIST or NET
1.Adaptation to perform partial resection
Key exclusion criteria 1.Advanced cancer
2.need systematic therapy of infeciton
3.need systematic therapy of anti-cancer drug.
4.need systematic thrapy of steroid
5.pregnancy or lacting
6.no more than 3 year prognosis
7.the physician judges to be inappropriate
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Okada
Organization Okayama University hospital
Division name Department of gastroenterology
Zip code 700-8558
Address 2-5-1, shikata-cho, kita-ku, okayama
TEL 086-235-7219
Email hiro@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Hiromitsu
Middle name
Last name Kanzaki
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Gastroenterology and Hepatology
Zip code 700-8558
Address 2-5-1, shikata-cho, kita-ku, okayama
TEL 086-235-7219
Homepage URL
Email kanzaki@qc4.so-net.ne.jp

Sponsor
Institute Okayama University hospital, department of gastroenterology
Institute
Department

Funding Source
Organization Okayama University hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, shikata-cho, kita-ku, okayama
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.jp

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
2017 Year 06 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 20 Day
Date of IRB
2017 Year 07 Month 18 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 09 Month 01 Day
Date analysis concluded
2021 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030683

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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