UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027606 |
|---|---|
| Receipt number | R000031192 |
| Scientific Title | Clinical outcome of combined metallic stent placement in malignant biliary and duodenal obstruction |
| Date of disclosure of the study information | 2017/06/02 |
| Last modified on | 2017/12/01 15:11:54 |
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Basic information
Public title
Clinical outcome of combined metallic stent placement in malignant biliary and duodenal obstruction
Acronym
Clinical outcome of double stenting
Scientific Title
Clinical outcome of combined metallic stent placement in malignant biliary and duodenal obstruction
Scientific Title:Acronym
Clinical outcome of double stenting
Region
| Japan |
Condition
Condition
Malignant biliary and duodenal obstruction
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with double stenting (DS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the clinical outcomes related to biliary and duodenal self-expandable metal stents (SEMS) in patients with DS.
Key secondary outcomes
Compared the adverse events and patency of biliary and duodenal SEMS using duodenal Uncovered SEMS and Covered SEMS.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Malignant bilioduodenal obstruction patients, who consent to participate in the study in Nagoya City University Hospital and research cooperation facilities
Key exclusion criteria
Not obtained the consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuki Hori |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL
+81-52-853-8211
yhori@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itaru Naitoh |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL
+81-52-853-8211
Homepage URL
inaito@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
Nagoya Daini Red cross Hospital,
Gifu Prefectural Tajimi Hospital,
Kasugai Municipal Hospital,
Nagoya City West Medical Center
Toyokawa City Hospital
Japan Community Health Care Organization
Gamagori City Hospital
Name of secondary funder(s)
None
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
名古屋第二赤十字病院（愛知県）、岐阜県立多治見病院（岐阜県）、春日井市民病院（愛知県）、名古屋市西部医療センター（愛知県）、豊川市民病院（愛知県）、中京病院（愛知県）、蒲郡市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28902972
Number of participants that the trial has enrolled
Results
BACKGROUND:
Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS.
METHODS:
Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]).
RESULTS:
A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (p = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent (C-SEMS) group than in the U-SEMS group (p = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (p = 0.724).
CONCLUSIONS:
Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. C-SEMS is the preferred type of duodenal SEMS in patients with DS.
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
| 2004 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 02 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 02 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 02 | Day |
Other
Other related information
Samples are collected from subjects who participated in this study in Nagoya City University Hospital and research affiliated facilities.
Samples and clinical information without containing personal information are numbered and managed in Nagoya City University Hospital. Consecutive paitents who underwent metallic stenting for malignant bilioduodenal obstruction in affiliated institutions from 2004.
Management information
Registered date
| 2017 | Year | 06 | Month | 02 | Day |
Last modified on
| 2017 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031192
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| Registered date | File name |
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