UMIN-CTR Clinical Trial

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
Institute	Southern Tohoku General Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031780