UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000542 |
|---|---|
| Receipt number | R000000660 |
| Scientific Title | Feasibility study of percutaneus endoscopic gastrostomy with Direct IDEAL PEG for patients with active head and neck cancer and esophageal cancer. |
| Date of disclosure of the study information | 2007/01/01 |
| Last modified on | 2006/12/09 15:39:02 |
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Basic information
Public title
Feasibility study of percutaneus endoscopic gastrostomy with Direct IDEAL PEG for patients with active head and neck cancer and esophageal cancer.
Acronym
Feasibility study of Direct IDEAL PEG
Scientific Title
Feasibility study of percutaneus endoscopic gastrostomy with Direct IDEAL PEG for patients with active head and neck cancer and esophageal cancer.
Scientific Title:Acronym
Feasibility study of Direct IDEAL PEG
Region
| Japan |
Condition
Condition
patients with active head and neck cancer and esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
feasibility of percutaneus endoscopic gastrostomy with Direct IDEAL PEG for patients with active head and neck cancer and esophageal cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
completion rate of PEG
Key secondary outcomes
Incidence of adverse event
Incidence of severe adverse event
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
| Device,equipment |
Interventions/Control_1
PEG
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
patients with active head and neck cancer and esophageal cancer
performance status:0,1,2
written informed concent
laboratory data within 2 weeks before entry
WBC > 2500/mm3
Platelet > 7.5x104/mm3
Creatinine>2.0 mg/dl
Total bilirubin>3.0 mg/dl
AST, ALT>within 5 times of limitation of our hospital
Key exclusion criteria
1. impossible of passage of endoscopy
2. exsisting of fistula
3. after gastrectomy
4. active infection
5. risk of GI bleeding
6. massive ascites
7. disapproval of withdraw of anti coaguration agent
8. addiction of steroids
9. severe heart disease and uncontrolled hypertention and diabete
10. terminal stage within 4 months prognosis
11. ineligible judged by doctor in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
National Cancer Center Hospital East
Division name
Division Digestive Endoscopy and GI Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Yano |
Organization
National Cancer Center Hospital East
Division name
Division Digestive Endoscopy and GI Oncology
Zip code
Address
TEL
Homepage URL
toyano@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Olympus
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 01 | Month | 01 | 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
Date of protocol fixation
| 2006 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 08 | Day |
Last modified on
| 2006 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000660
