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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003742
Receipt No. R000004529
Scientific Title Effects of CO2 insufflation using a duodenal balloon occlusion method on intestinal tract volume and arterial blood acid-base balance during endoscopic submucosal dissection and natural orifice translumenal endoscopic surgery
Date of disclosure of the study information 2010/06/12
Last modified on 2012/06/14

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Basic information
Public title Effects of CO2 insufflation using a duodenal balloon occlusion method on intestinal tract volume and arterial blood acid-base balance during endoscopic submucosal dissection and natural orifice translumenal endoscopic surgery
Acronym Duodenal balloon occlusion method
Scientific Title Effects of CO2 insufflation using a duodenal balloon occlusion method on intestinal tract volume and arterial blood acid-base balance during endoscopic submucosal dissection and natural orifice translumenal endoscopic surgery
Scientific Title:Acronym Duodenal balloon occlusion method
Region
Japan

Condition
Condition Early esophageal cancer or early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of CO2 insufflation on intestinal tract volume and arterial blood acid-base balance in patients undergoing ESD or NOTES between a duodenal balloon occlusion group and a non-occlusion group
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Changes in CO2 concentration at 10-minute intervals during surgery
2.Pre-and postoperative arterial blood gases,intestinal tract volumes,WBC and CRP
3.Postoperative abdominal symptoms assessed by visual analogue scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 A balloon is inserted into duodenal bulb.
CT scans are carried out before and after the ESD.
Arterial blood gas analysis are carried out before and after the ESD.
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
30 years-old <=
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria Patients who are early esophageal cancer and early gastric cancer and going to undergo ESD
Key exclusion criteria Patients who have duodenal ulcer in past history
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name hirohito mori
Organization Kagawa university
Division name Department of gastroenterology
Zip code
Address 1750-1 ikedo miki town kida county kagawa prefecture
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kagawa university
Division name IRB
Zip code
Address
TEL 087-891-2156
Homepage URL
Email chiken-b@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa university
Institute
Department

Funding Source
Organization Kagawa university
Organization
Division
Category of Funding 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
2010 Year 06 Month 12 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
2010 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 12 Day
Last modified on
2012 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004529

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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