UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032797 |
|---|---|
| Receipt number | R000037415 |
| Scientific Title | Evaluation of the efficacy of ZEO STENT TM plus with a 14mm diameter for the distal biliary obstruction by pancreatic cancer. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2023/12/05 06:22:05 |
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Basic information
Public title
Evaluation of the efficacy of ZEO STENT TM plus with a 14mm diameter for the distal biliary obstruction by pancreatic cancer.
Acronym
Evaluation of ZEO STENT TM plus.
Scientific Title
Evaluation of the efficacy of ZEO STENT TM plus with a 14mm diameter for the distal biliary obstruction by pancreatic cancer.
Scientific Title:Acronym
Evaluation of ZEO STENT TM plus.
Region
| Japan |
Condition
Condition
Distal biliary obstruction by pancreatic cancer.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the patency and the safety of ZEO STENT TM plus, a metal stent with a 14mm diameter, for distal biliary obstruction by pancreatic cancer. There is no previous report about the stent, and this study is aimed to clarify the efficacy of the stent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of recurrent biliary obstruction
Key secondary outcomes
Stent patency duration
Stent patency duration and the rate of stent function estimated by the Kaplan-Meier method
Median overall survival
Rate of complication
Adverse events in the therapeutic period and post therapeutic period
Complications related ERCP
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) Distal biliary obstruction by pancreatic cancer
2) Expected survive more than 2 months
3) Age: >= 20 years at the time of acquiring consent
4) Written informed consent
5) ECOG Performance Status of 0-1
Key exclusion criteria
1)Massive ascites.
2)Uncontrolled other organ diseases
3)Biliary obstruction at the hilar part.
4)Unachievable ERCP due to post-abdominal surgery state including gastrectomy.
5)Unachievable ERCP due to difficult cannulation.
6)Distal duodenal obstruction. (Post-treatment state by stent placement excluded.)
7) Inappropriate patients for study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nakahodo |
Organization
Cancer and Infection Disease Center Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
TEL
03-3823-2101
nakajun58@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nakahodo |
Organization
Cancer and Infection Disease Center Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
TEL
03-3823-2101
Homepage URL
nakajun58@yahoo.co.jp
Sponsor or person
Institute
Cancer and Infection Disease Center Komagome 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
Cancer and Infection Disease Center Komagome Hospital
Address
3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
Tel
03-3823-2101
rinri@cick.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
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
An uncovered and a covered metal stent were developed for relieving jaundice with a long-term patency. However, stent occlusion due to tumor ingrowth and stent migration were frequently experienced in an uncovered and a covered metal stent, respectively. Being uncovered and a large diameter of a stent could contribute to preventing recurrent biliary obstruction due to tumor ingrowth or migration.
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037415
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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