UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001819 |
|---|---|
| Receipt number | R000001979 |
| Scientific Title | Prospective study of endoscopic submucosal dissection for early gastric cancer |
| Date of disclosure of the study information | 2009/03/30 |
| Last modified on | 2013/04/20 12:41:35 |
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Basic information
Public title
Prospective study of endoscopic submucosal dissection for early gastric cancer
Acronym
ESD for early gastric cancer
Scientific Title
Prospective study of endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym
ESD for early gastric cancer
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is this study is to evaluate the efficacy and safety of endoscopic submucosal dissection for early gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of complete resection
Key secondary outcomes
Rate of local reccurrence rate, safety, rate of stomach preservation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic submucosal dissection
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed differentiated adenocarcinoma of the stomach
2) Age of 20-80 years
3) ECOG performance status of 0 to 2
4) Early gastric cancer with single and non recurrence tumor
5) Intramucosal cancer within 20mm in diameter
6) Without ulceration or scar
7) One-piece resection is possible with ESD
8) Adequate organ function
9) Written informed consent
Key exclusion criteria
1) History of gastrectomy
2) Active other malignancies
3) Uncontrollable diabetes mellitus
4) Uncontrollable hypertension
5) History of severe heart disease
6) Anticoagulant or antiplatelet medications
7) Active infection
8) Psychosis
9) Not appropriate for the study at the physician's assessment
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumu Hosokawa |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
2630 Sugitani, Toyama, 930-0194, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hokkaido ESD Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2005 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | 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
| 2009 | Year | 03 | Month | 30 | Day |
Last modified on
| 2013 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001979
