UMIN-CTR Clinical Trial

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
Institute	Southern Tohokou General Hospital
Institute
Department

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
URL(English)	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

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