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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028232
Receipt No. R000031536
Scientific Title Observational study of ghrelin producing cells at remant stomach after disal gastrectomy
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/14

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Basic information
Public title Observational study of ghrelin producing cells at remant stomach after disal gastrectomy
Acronym Ghrelin profile study after gastrectomy
Scientific Title Observational study of ghrelin producing cells at remant stomach after disal gastrectomy
Scientific Title:Acronym Ghrelin profile study after gastrectomy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examination of the ghrelin level before and after distal gastrectomy
Basic objectives2 Others
Basic objectives -Others Examination of the ghrelin-producing ability before and after distal gastrectomy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative serum ghrelin level
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
85 years-old >
Gender Male and Female
Key inclusion criteria Case of primary gastric cancer which diagnosis was provided histologically.
Case of distal gastrectomy.
Case which was taken as possibility by a diagnosis of R0 resection before the operation.
Case of H0, P0, M0.
Case of PS 0 to 2.
The case that maintains the marrow, liver, renal function shown below.
WBC: more than 3,000/mm3, less than 12,000/mm3
Plt: more than 10x104/mm3
Hb: more than 8g/dL
AST,ALT:less than twice the facilities standard value
Total Bil: lower than 2.0 mg/dL
Creatinine: lower than 1.5 mg/dL
Case of no past history of the epigastric region operation nor past history of the operation of intestinal resection. But appendicectomy for appendicitis is excluded.
The case that an agreement was provided in a document by the patient.
Key exclusion criteria Overlap cancer.
Case that has an infectious disease which requires systemic treatment.
Case that has fever more than 38 degrees celcius.
Case of pregnancy, with the possibility of pregnancy, or lacating.
Case that has mental disease or a mind symptom, and is judged to be difficult to participate in study.
Case that receive continuous use of the steroid.
Case with unstable angina (angina that the onset or an attack aggravates recently within three weeks) or have a past history of myocardial infarction within six months.
Case with hypertension which is poorly controled.
Case of diabetes having poor in treatment or control by continuous use of insulin.
Case of pulmonary disease which requires sustained oxygen dosage.
Case of renal insufficiency which requires blood, peritoneum dialysis.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka
TEL +81-6-6879-3251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Miyazaki
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka
TEL 81-6-6879-3251
Homepage URL
Email ymiyazaki02@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
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
Address
Tel
Email

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
2017 Year 08 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
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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No important notice

Management information
Registered date
2017 Year 07 Month 14 Day
Last modified on
2017 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031536

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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