UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004942 |
|---|---|
| Receipt number | R000005705 |
| Scientific Title | Randomized controlled study of Flush knife versus Mucosectome in endoscopic submucosal dissection for superficial esophageal cancer |
| Date of disclosure of the study information | 2011/01/25 |
| Last modified on | 2012/07/26 23:13:14 |
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Basic information
Public title
Randomized controlled study of Flush knife versus Mucosectome in endoscopic submucosal dissection for superficial esophageal cancer
Acronym
Randomized study comparing ESD device.
Scientific Title
Randomized controlled study of Flush knife versus Mucosectome in endoscopic submucosal dissection for superficial esophageal cancer
Scientific Title:Acronym
Randomized study comparing ESD device.
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Mucosectome compared with Flush knife in esophageal ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Procedure time of submucosal dissection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ESD using Flush knife
Interventions/Control_2
ESD using Mucosectome
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
Superficial esophageal squamous cell carcinoma 15mm - 50mm in diameter, circumferential spread 1/2 or less.
Key exclusion criteria
1)Patients with past history of operation, chemotherapy or radiotherapy for esophageal cancer.
2)Local recurrence after endoscopic resection.
3)Patients with iodine allergy.
4)Lesions those are extending into pharyngoesophageal junction or esophago-gastric junction.
5)Patients with esophageal lesion in the area of reflux esophagitis.
6)Patients with hematological abnormality.
7)Patients with severe organ failure
8)Patients who have been judged as inappropriate for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, 537-8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Kanzaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
Address
TEL
Homepage URL
kanzai-hi@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
大阪府立成人病センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2012 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005705
