UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021065 |
|---|---|
| Receipt number | R000024287 |
| Scientific Title | Study of the upper gastrointestinal tract peristalsis inhibitory effect of acupuncture in endoscopic submucosal dissection for early gastric cancer |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2017/08/24 09:10:38 |
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Basic information
Public title
Study of the upper gastrointestinal tract peristalsis inhibitory effect of acupuncture in endoscopic submucosal dissection for early gastric cancer
Acronym
Study of peristalsis inhibitory effect of acupuncture in ESD
Scientific Title
Study of the upper gastrointestinal tract peristalsis inhibitory effect of acupuncture in endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym
Study of peristalsis inhibitory effect of acupuncture in ESD
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to establish a procedure to use acupuncture to inhibit the peristalsis of the upper gastrointestinal tract during endoscopic submucosal dissection for early gastric cancer, its feasibility and safety are considered.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the peristaltic movement and ease of the operation using the Niwa Classification by physician who gives the endoscopic submucosal dissection
Key secondary outcomes
Evaluation of the ease of the operation using VAS by physician
Evaluation of the peristalsis inhibitory effect from video image
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
In case gastrointestinal tract peristalsis is found acupuncture to "Zhongwan" in the abdomen.
Interventions/Control_2
In case gastrointestinal tract peristalsis is found scopolamine butylbromide 20mg intravenous administration.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with early stage of gastric cancer (invasion depth T1)
Patients whose overall condition is considered stable (no signs of infection within one week prior to operation and no steep deterioration of symptoms related to cancer, and medication is stable in amount and content) by their physicians in charge
Patients who are able to communicate and able to understand the contents of the study
Key exclusion criteria
Patients who have history of partial gastrectomy
Patients who has complication of uncontrolled diabetes or severe heart disease
Patients who are not able to communicate due to severe mental disability or dementia
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Irisawa |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL
0242-75-2100
irisawa@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Suzuki |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Kampo Medicine
Zip code
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL
0242-75-2100
Homepage URL
masuzuki@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
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
福島県立医科大学会津医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 17 | Day |
Last modified on
| 2017 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024287
