UMIN-CTR Clinical Trial

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
Email	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
Email	masuzuki@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040609