UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021347 |
|---|---|
| Receipt number | R000024615 |
| Scientific Title | Feasibility and efficacy of EUSguided drainage and endoscopic necrosectomy using a novel lumen-apposing metal stent |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2019/03/07 23:29:24 |
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Basic information
Public title
Feasibility and efficacy of EUSguided drainage and endoscopic necrosectomy using a novel lumen-apposing metal stent
Acronym
Efficacy of a novel lumen-apposing metal stent
Scientific Title
Feasibility and efficacy of EUSguided drainage and endoscopic necrosectomy using a novel lumen-apposing metal stent
Scientific Title:Acronym
Efficacy of a novel lumen-apposing metal stent
Region
| Japan |
Condition
Condition
walled-off necrosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical treatment rate for WON
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical treatment rate for WON
Key secondary outcomes
Base
Study type
Interventional
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
| Device,equipment | Maneuver |
Interventions/Control_1
EUS-guided drainage and direct endoscopic necrosectomy using a novel metal stent
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with symptomatic sterile or infected walled-off necrosis, which can be punctured safely from stomach or duodenum under endoscopic ultrasound.
2)Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria
1)Cases with sever complication in other organs except original disease
2)Cases having impossibility of cessation of anticoagulant
3)Cases with pregnancy or suspect of pregnancy
4)Cases with malignant cancer not having more than a half year prognosis
5)Cases that the size of lesion is less than 3 cm
6)Cases having difficulty in endoscopic approach
7)Cases having difficulty in visualization of lesion on EUS
8)Cases judged by principal investigator to be inadequate as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Itoi |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
itoi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuntaro Mukai |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
s-mukai@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and
Hepatology, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and
Hepatology, Tokyo Medical University
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
