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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002191
Receipt No. R000002072
Scientific Title A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Date of disclosure of the study information 2009/07/13
Last modified on 2009/07/13

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Basic information
Public title A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Acronym A randomized double-blind controlled study of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Scientific Title A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Scientific Title:Acronym A randomized double-blind controlled study of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Region
Japan

Condition
Condition large superficial colorectal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of en-bloc resection.
The mean operation time.
The score of abdominal distension and pain immediately and 1 hour after the procedure.
Key secondary outcomes The rate of complication.
The amount of sedative administered during the procedure.
The amounts of gas in the intestine, immediately and 1 hour after the procedure.
difference of the abdominal circumference before and immediately after the procedure.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To assess the influence of the air insufflation to the success rate of colorectal ESD and the patient's discomfort during the procedure, and the association of harmful events.
The study period will be from approval until 31 March 2010.
Interventions/Control_2 To assess the influence of the carbon dioxide insufflation to the success rate of colorectal ESD and the patient's discomfort during the procedure, and the association of harmful events.
The study period will be from approval until 31 March 2010.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with superficial colorectal tumor larger than 2cm.
Key exclusion criteria Patients for whom colorectal tumor resection cannot be expected to improve survival prognosis due to serious underlying disease (advanced cancer, severe infection, serious respiratory disease or cardiovascular disease)
Patients who are under age or have dementia, or who cannot grant informed consent themselves for some other comparable reason.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Miyata
Organization Jichi Medical University
Division name Endoscopy center
Zip code
Address 3311-1, yakushiji, shimotuke-shi, tochigi pref. Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jichi Medical University
Division name Endoscopy center
Zip code
Address
TEL
Homepage URL
Email s2k@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Fuji Film Corporation
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
2009 Year 07 Month 13 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
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 03 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 07 Month 13 Day
Last modified on
2009 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002072

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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