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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035650
Receipt No. 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 2019/01/23

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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 Single blind -investigator(s) and assessor(s) 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
Middle name
Last name Goro Shibukawa
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
Email goro4649@aol.com

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
Email masuzuki@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
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
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 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
Anticipated trial start date
2019 Year 02 Month 14 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
2019 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040609

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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