UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032669
Receipt number R000037252
Scientific Title Safety Evaluation of drinking on post-gastrectomy patients
Date of disclosure of the study information 2018/06/01
Last modified on 2021/08/17 14:09:32

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Basic information

Public title

Safety Evaluation of drinking on post-gastrectomy patients

Acronym

Safety Evaluation of drinking on post-gastrectomy patients

Scientific Title

Safety Evaluation of drinking on post-gastrectomy patients

Scientific Title:Acronym

Safety Evaluation of drinking on post-gastrectomy patients

Region

Japan


Condition

Condition

post-gastrectomy patients

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety Evaluation of drinking on post-gastrectomy patients

Basic objectives2

Others

Basic objectives -Others

Investigation of drinking on postgastrectomy
patient

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Absorption and decomposition rate of alcohol

Key secondary outcomes

Adverse event (Nausea, vomiting, indisposition, headaches, fatigue) incidence up to 24 hours after drinking alcohol


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Food

Interventions/Control_1

post-gastrectomy patients

Interventions/Control_2

Healthy person

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Outpatient of our hospital
2. Patients who underwent po st-gastrectomy(with lymphadenectomy) for gastric cancer
3. Patients who have not recurred for more than 1 year after surgery
4. Patients who had taken habitual alcohol intake before surgery
5. Patients who received written consent for participation in the study

Key exclusion criteria

1. Alcohol hypersensitivity patients
2. History of liver function disorder
3. History of alcohol abuse
4. Taking any anti-neoplastic agent
5. Under treatment for other malignant disease
6. Taking any drugs designed as contraindication with alcohol intake
7. No drinking habit before surgery
8. Less than 20 years old

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Michitaka
Middle name
Last name Honda

Organization

Fukushima Medical University

Division name

Department of Minimally Invasive Surgical and Medical Oncology

Zip code

960-1247

Address

Hikarigaoka 1, Fukushima-shi, Fukushima

TEL

024-547-1111

Email

mhonda@fukuhsimamed.com


Public contact

Name of contact person

1st name Masatake
Middle name
Last name Tamaki

Organization

Fukushima Medical University

Division name

Department of Minimally Invasive Surgical and Medical Oncology

Zip code

960-1247

Address

Hikarigaoka 1, Fukushima-Shi, Fukushima

TEL

024-547-1111

Homepage URL


Email

tamaki@japanscr.org


Sponsor or person

Institute

Southern Tohokou General Hospital

Institute

Department

Personal name



Funding Source

Organization

Southern Tohokou General Hospital

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

Sougou Minamitouhoku hospital

Address

Fukushimaken Kooriyama-shi Hachiyamada 7-115

Tel

024-934-5322

Email

kensyu@mt.strins.or.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

総合南東北病院(福島県)


Other administrative information

Date of disclosure of the study information

2018 Year 06 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

25

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

2018 Year 04 Month 26 Day

Date of IRB

2018 Year 02 Month 01 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2019 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 22 Day

Last modified on

2021 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037252


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name