UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003565 |
|---|---|
| Receipt number | R000004325 |
| Scientific Title | Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer (JIVROSG-0805) |
| Date of disclosure of the study information | 2010/05/05 |
| Last modified on | 2019/05/19 15:56:24 |
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Basic information
Public title
Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer (JIVROSG-0805)
Acronym
Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction
Scientific Title
Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer (JIVROSG-0805)
Scientific Title:Acronym
Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction
Region
| Japan |
Condition
Condition
Gastrointestinal obstruction from cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer comparing with conventional nasal gastric tubing.
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 nasal gastric tubing.
Key secondary outcomes
Improvement of health-related QOL and toxicity profile.
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 | Maneuver |
Interventions/Control_1
Percutaneous transesophageal gastric tubing (PTEG)
Interventions/Control_2
Nasal gastric tubing
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. Gastrointestinal obstruction from cancer, such as upper GI obstruction from tumor or peritonitis, without possibility of symptom improvement by conventional treatments.
2. Contraindication to surgical treatments for gastrointestinal obstruction.
3. No disorder in the region of cervical esophagus.
4. Palliative prognosis index less than 6.
5. Twice measurement of symptom score and health-related quality-of-life.
6. Written informed consent from the patients.
Key exclusion criteria
1. Tracheal stoma by tracheostomy.
2. GI obstruction resulting from the lesion distal (annal side) to transverse colon.
3. Platelet count <50,000/mm3.
4. Locoregional treatment in the neck or planned locoregional treatment in the neck.
5. Pregnancy.
6. Contraindication decided by participating physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Aramaki |
Organization
Shizuoka Cancer Center
Division name
Department of Imaging Diagnosis
Zip code
411-8777
Address
Shunto-gun, Shizuoka, Japan
TEL
03-3542-2511
msone@athena.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Arai |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
1040045
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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
Tel
03-3542-2511
msone@me.com
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）、群馬大学医学部附属病院（群馬県）、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）、手稲渓仁会病院（北海道）、栃木県立がんセンター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
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 | 05 | Day |
Last modified on
| 2019 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004325
