UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000042 |
|---|---|
| Receipt number | R000000082 |
| Scientific Title | A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205) |
| Date of disclosure of the study information | 2005/08/06 |
| Last modified on | 2010/02/11 14:27:02 |
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Basic information
Public title
A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205)
Acronym
Percutaneous trans-esophageal gastric tubing (JIVROSG-0205)
Scientific Title
A phase II study of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction (JIVROSG-0205)
Scientific Title:Acronym
Percutaneous trans-esophageal gastric tubing (JIVROSG-0205)
Region
| Japan |
Condition
Condition
Malignant gastrointestinal obstruction
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Breast surgery |
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of percutaneous trans-esophageal gastric tubing for malignant gastrointestinal obstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Improvement of subjective symptoms compared to previous nasal tubing.
Key secondary outcomes
Adverse events and feasibility of procedure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Under local anesthesia and fluoroscopy or ultrasonic guidance, a percutaneous route to cervical esophagus is made by direct puncture to the intra-esophageal balloon inserted via nasal or oral route, and then, a drainage tube is placed from the neck surface to the stomach using this route.
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
1) No expectation for removal of nasal tube caused by persistent and malignant gastro-intestinal obstruction.
2) No pathological condition around cervical esophagus.
3) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
5) Expected survival more than 4 weeks.
6) Written informed consent.
Key exclusion criteria
1) Tracheostomy.
2) Intestinal obstruction due to the lesions between transverse colon and rectum.
3) Pregnancy.
4) Local therapy for neck region
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Aramaki |
Organization
Shizuoka Cancer Center
Division name
Department of Imaging Diagnosis
Zip code
Address
1007, Shimonagakubo, Nagaizumi-cho, Shuntoh-gun, Shizuoka 411-8777, Japan
TEL
055-982-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Arai |
Organization
JIVROSG, Coordinating Office
Division name
Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Homepage URL
http://jivrosg.umin.jp/
jivrosgoffice@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
http://jivrosg.umin.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Technical success rate: 100%
Average required time for procedure: 28.5 min
Clinical efficacy: 91%
Mortality within 30 days: 5 (All caused by progression of primary disease)
Procedure related Adverse events (>Grade 2): Broncho-esophageal fistula
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
| 2002 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 06 | Day |
Last modified on
| 2010 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000082
