UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014579 |
|---|---|
| Receipt number | R000016957 |
| Scientific Title | A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction |
| Date of disclosure of the study information | 2014/07/22 |
| Last modified on | 2016/07/17 20:28:26 |
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Basic information
Public title
A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction
Acronym
ARMS as a reintervention
Scientific Title
A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for recurrent obstruction of covered metal stent for distal malignant biliary obstruction
Scientific Title:Acronym
ARMS as a reintervention
Region
| Japan |
Condition
Condition
Nonresectable distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare antireflux metal stent and conventional covered metal stent for recurrent occlusion of conventional covered metal stent as a result of sludge or food impaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstrution after the placement of metal stent
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic placement of antireflux metal stent for biliay obstruction
Interventions/Control_2
Endoscopic placement of conventional covered metal stent for biliay obstruction
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. nonresectable malignant biliary obstruction
2. distal biliary obstruction (2 cm or longer from the bifurcation)
3. Covered metal stent was occluded due to the duodenobiliary reflux within 90 days of stent placement, and cholantitis subsided via endoscopic biliary drainage
4. Irrespective of sex and a primary disease
5. Written informed consent obtained
Key exclusion criteria
1. Endoscopic approach to the biliary system is impossible
2. Hilar biliary obstruction
3. Performance status is four
4. Gastrointestinal obstruction distal to the papilla (patients whose gastrointestinal obstruction was resolved via a stent or surgical bypass can be included)
5. Severe comobidities in other organs
6. Pregnant women or those suspected of pregnancy
7. Written informed consent not obtained
8. Patients considered ineligible by attending physicians
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology,
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology,
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-3815-5411
Homepage URL
isayama-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Century Medical, Inc.
Organization
Division
Category of Funding Organization
Profit 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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 22 | 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 | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 06 | 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 | 07 | Month | 17 | Day |
Last modified on
| 2016 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016957
