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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000542
Receipt No. 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

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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
Email

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
Email toyano@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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