UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the upper gastrointestinal tract peristalsis inhibitory effect of acupuncture in endoscopic submucosal dissection for early gastric cancer
Title of the study (Brief title)	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	Atsushi Irisawa
Organization	Aizu Medical Center, Fukushima Medical University
Division name	Department of Gastroenterology
Address	21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL	0242-75-2100
Email	irisawa@fmu.ac.jp

Public contact
Name of contact person	Masao Suzuki
Organization	Aizu Medical Center, Fukushima Medical University
Division name	Department of Kampo Medicine
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024287