UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003742 |
|---|---|
| Receipt number | 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 15:15:46 |
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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
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
chiken-b@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004529
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
