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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | post-gastrectomy patients | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
mhonda@fukuhsimamed.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |