UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036973 |
|---|---|
| Receipt number | R000041642 |
| Scientific Title | Prospective cohort study of duodenal laparoscopy-endoscopy cooperative surgery for non-ampullary duodenal tumor |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2023/12/08 13:58:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective cohort study of duodenal laparoscopy-endoscopy cooperative surgery for non-ampullary duodenal tumor
Acronym
Prospective study of D-LECS
Scientific Title
Prospective cohort study of duodenal laparoscopy-endoscopy cooperative surgery for non-ampullary duodenal tumor
Scientific Title:Acronym
D-LECS study
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal tumor, non-ampullary duodenal submuocsal tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of duodenal laparoscopy-endoscopy cooperative surgery (LECS) for non-ampullary duodenal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of treatment
Key secondary outcomes
Adverse event, Treatment time, Hospital stay, Recurrence rate
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
1-1. Superficial non-ampullary duodenal tumor (SNADET) larger than 2cm in size
1-2. SNADET that will not be able to closepost-ESD ulcer
1-3. Duodenal submucosal tumor (SMT) without ulcer larger than 1cm
2. Age older than 20 years
Key exclusion criteria
1. Duodenal tumor that can not be cured with local resection
2. Duodenal ampullary tumor
3. Contraindication for laparoscopic surgery
4. Contraindication for general anethesia, including severe heart and lung failure.
5. A paient without consent
6. Inappropriate case by physician's judgement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Kataoka |
Organization
Nagoya City University Hospital
Division name
Department of Gastroenterology
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
hkataoka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Hospital
Division name
Department of Gastroenterology
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
Homepage URL
tshimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,
Department of Surgery,
Nagoya City University Hospital
Institute
Department
Personal name
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
Clinical Research Management Center, Nagoya City University Hospital
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8602, Japan
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041642
