UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045173
Receipt number R000031780
Scientific Title Breath Alcohol Concentration Assessment for patients after gastrectomy
Date of disclosure of the study information 2021/08/17
Last modified on 2021/08/17 13:48:23

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Basic information

Public title

Breath Alcohol Concentration Assessment for patients after gastrectomy

Acronym

BACCAS-G trial

Scientific Title

Breath Alcohol Concentration Assessment for patients after gastrectomy

Scientific Title:Acronym

BACCAS-G trial

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The safety evaluation of alcohol drinking on patients after gastrectomy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

The time trend of breath alcohol concentration after drinking

Key secondary outcomes

Hangover symptoms


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

1 unit Alcohol intake

Interventions/Control_2


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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Outpatients who underwent total gastrectomy and lymphonode dissection for gastric cancer.
No recurrence over 1 year follow-up.
Originally drinker.


Key exclusion criteria

Hypersensitivity for drinking
Elevation of LFTs
History of addiction of alcohol
Under administration of Anti-cancer agent or other drugs prohibited drinking
Under treatment for other malignant diseases

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Honda
Middle name
Last name Michitaka

Organization

Fukushima medical university

Division name

Minimally invasive surgical and medical oncology

Zip code

960-1247

Address

Hikarigaoka 1 Fukushima, Japan

TEL

024-547-1111

Email

mhonda@fukushimamed.com


Public contact

Name of contact person

1st name Kobayashi
Middle name
Last name Hiroshi

Organization

Southern Tohoku General Hospital

Division name

Surgery

Zip code

963-8052

Address

Yatsuyamada 7-115 Koriyama, Fukushima

TEL

024-934-5322

Homepage URL


Email

mhonda@fukushimamed.com


Sponsor or person

Institute

Southern Tohoku General Hospital

Institute

Department

Personal name



Funding Source

Organization

Southern Tohoku General Hospital

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

Southern Tohoku General Hospital

Address

Yatsuyamada 7-115 Koriyama, Fukushima

Tel

024-934-5322

Email

mhonda1017@yahoo.co.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



Other administrative information

Date of disclosure of the study information

2021 Year 08 Month 17 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

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 02 Month 15 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2022 Year 07 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

2021 Year 08 Month 17 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=R000031780


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name