UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035650 |
|---|---|
| Receipt number | R000040609 |
| Scientific Title | Study of the upper gastrointestinal tract peristalsis inhibitory effect of acupuncture in endoscopic submucosal dissection for early gastric cancer: A randomized controlled trial. |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2020/07/25 11:00:59 |
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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: A randomized controlled trial.
Acronym
Study of peristalsis inhibitory effect of acupuncture in ESD: A randomized controlled trial.
Scientific Title
Study of the upper gastrointestinal tract peristalsis inhibitory effect of acupuncture in endoscopic submucosal dissection for early gastric cancer: A randomized controlled trial.
Scientific Title:Acronym
Study of peristalsis inhibitory effect of acupuncture in ESD: A randomized controlled trial.
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
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 using the Niwa Classification by another endoscopist not attending the surgery.
(Evaluation of the peristalsis inhibitory effect from the video image)
Key secondary outcomes
1 Evaluation of the ease of the operation using modified Niwa Classification and VAS by a physician.
2 Evaluation of contingency cases during surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| 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 Glucagon 1mg 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
1 Patients with the early stage of gastric cancer (invasion depth T1)
2 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
3 Patients who are able to communicate and able to understand the contents of the study
Key exclusion criteria
1 Patients who have a history of partial gastrectomy
2 Patients who have the complication of uncontrolled diabetes or severe heart disease
3 Patients who are not able to communicate due to severe mental disability or dementia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Goro |
| Middle name | |
| Last name | Shibukawa |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
9693492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL
0242-75-2100
goro4649@aol.com
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Suzuki |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Kampo Medicine
Zip code
9693492
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
Fukushima Medical University
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
Fukushima Medical University Clinical Research Ethics Committee
Address
1 Hikarigaoka Fukushima city, Fukushima
Tel
024-548-2111
rs@fmu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040609
