UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015322 |
|---|---|
| Receipt number | R000017814 |
| Scientific Title | Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial |
| Date of disclosure of the study information | 2014/10/02 |
| Last modified on | 2017/10/04 15:09:13 |
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Basic information
Public title
Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial
Acronym
Endoscopic treatment for walled-off necrosis using plastic stents vs. biflanged metal stent, prospective randomized controlled trial
Scientific Title
Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial
Scientific Title:Acronym
Endoscopic treatment for walled-off necrosis using plastic stents vs. biflanged metal stent, prospective randomized controlled trial
Region
| Japan |
Condition
Condition
Walled-off necrosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of endoscopic treatment for walled-off necrosis using a novel biflanged metal stent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success rate, clinical success rate
adverse event rate, mortality rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the patients of PS group, conventional EUS guided transmural drainage using plastic stents is performed.
In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated biflanged metal stent is performed.
Interventions/Control_2
In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated biflanged metal stent is performed.
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
| 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
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itoi Takao |
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
itoitakao@gmail.com
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
maezora1031@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University Hospital Department of Gastroenterology and Hepatology
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
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
| 2014 | Year | 10 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2017 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017814
