UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032669
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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://upload.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


Contact us.