UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003572 |
|---|---|
| Receipt number | R000004332 |
| Scientific Title | Randomized controlled trial of stent placement in patients with inoperable malignant colorectal obstruction (JIVROSG-0806) |
| Date of disclosure of the study information | 2010/05/06 |
| Last modified on | 2013/05/06 19:43:48 |
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Basic information
Public title
Randomized controlled trial of stent placement in patients with inoperable malignant colorectal obstruction (JIVROSG-0806)
Acronym
Randomized controlled trial of stent placement in patients with malignant colorectal obstruction
Scientific Title
Randomized controlled trial of stent placement in patients with inoperable malignant colorectal obstruction (JIVROSG-0806)
Scientific Title:Acronym
Randomized controlled trial of stent placement in patients with malignant colorectal obstruction
Region
| Japan |
Condition
Condition
Malignant colorectal obstruction
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of stenting in patients with inoperable, symptomatic malignant colorectal obstruction comparing with other treatments in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Improvement of the symptoms from colorectal obstruction.
Key secondary outcomes
Improvement of health-related QOL, toxicity profile, and survival time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Stent placement in the region of colonic stenosis.
Interventions/Control_2
Other treatments except surgical intervention.
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
1. Inoperable, symptomatic obstruction in rectum or sigmoid cancer.
2. No clinical obstruction in oral side GI tract.
3. Difficulty in surgical colostomy or no refusal by the patient.
4. Palliative prognosis index less than 6.
5. Written informed consent from the patients.
6. Twice measurement of symptom score and health-related quality-of-life.
Key exclusion criteria
1. Indication for surgical colostomy.
2. Possibility of definitive surgery for colorectal obstruction.
3. Bleeding from the treatment area requiring hemostatic treatments.
4. More than 4 weeks after the beginning of the symptom from colorectal obstruction.
5. Clinically significant cardiac failure, renal failure, or bleeding tendency.
6. Difficulties in the evaluation of quality-of-life.
7. Pregnancy.
8. Contraindication decided by participating physician.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Inaba |
Organization
Aichi Cancer Center
Division name
Department of Diagnostic and Interventional Radiology
Zip code
Address
Nagoya, Aichi, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Arai |
Organization
National Cancer Center Hospital
Division name
Division of Diagnostic Radiology
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Homepage URL
http://jivrosg.umin.jp/
arai-y3111@mvh.biglobe.ne.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
愛知県がんセンター中央病院（愛知県）、旭川厚生病院（北海道）、岩手医科大学（岩手県）、国立がんセンター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）、栃木県立がんセンター（栃木県）、社会医療法人敬愛会中頭病院（沖縄県）、奈良県立医科大学（奈良県）、福岡大学病院（福岡県）、龍ヶ崎済生会病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 06 | 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
| 2009 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | 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
| 2010 | Year | 05 | Month | 06 | Day |
Last modified on
| 2013 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004332
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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