UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009061 |
|---|---|
| Receipt number | R000010603 |
| Scientific Title | Randomized study of two gastrointestinal metallic stent for malignant duodenal obstruction |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2024/01/28 10:49:40 |
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Basic information
Public title
Randomized study of two gastrointestinal metallic stent for malignant duodenal obstruction
Acronym
Randomized study of two gastrointestinal metallic stent for malignant duodenal obstruction
Scientific Title
Randomized study of two gastrointestinal metallic stent for malignant duodenal obstruction
Scientific Title:Acronym
Randomized study of two gastrointestinal metallic stent for malignant duodenal obstruction
Region
| Japan |
Condition
Condition
Malignant pancreatobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Advanced pancreatic cancer and biliary tract cancer progression when the invasion to the duodenum, resulting in non-oral intake and vomiting, QOL of the patient is reduced. As a result, the case that it is difficult to continue the treatment of cancer is often seen. Duodenal stent placement for malignant duodenal stenosis, improve the duodenal stenosis, significantly improve the QOL of patients. Further early oral intake and early discharge is possible, it is also expected on the medical economy. In this clinical study, compared the usefulness and safety of two stents for malignant duodenal stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change in GOO Scoring System Score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wallflex stent
Interventions/Control_2
Niti-s gastroduodenal stent
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.Duodenal stenosis in patients with malignant biliary tract cancer or pancreatic cancer
2.Aged 20 or over at the time of obtaining informed consent
3.Patients with agreement of this clinical study.
Key exclusion criteria
1.Patients without informed consent.
2.Patients who are not possible to communicate by mental disorder or disturbance of consciousness.
3.Patients malignant duodenal stenosis caused by malignant tumors other than biliary tract cancer and pancreatic cancer.
4.Patients with gastrointestinal perforation.
5.Patients with distal intestinal obstruction.
6.Postoperative Patients gastrojejunostomy.
7.Patients that can be a aggressive adaptation of gastrojejunostomy.
8.Patients who are judged inappropriate by medical examiner.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kida |
Organization
Kitasato University East Hospital
Division name
Department of Gstroenterology
Zip code
Address
2-1-1 Asamizodai Minami Sagamihara Kanagawa 252-0380 Japan
TEL
042-748-9111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Okuwaki |
Organization
Kitasato University East Hospital
Division name
Department of Gstroenterology
Zip code
Address
2-1-1 Asamizodai Minami Sagamihara Kanagawa 252-0380 Japan
TEL
042-748-9111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gstroenterology, Kitasato University School of Medicine
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
北里大学東病院（神奈川県）
Kitasato University East hospital (Kanagawa, Japan)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 09 | 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
| 2012 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010603
| 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 |
