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

Email

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


Email

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


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(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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name