UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of ghrelin producing cells at remant stomach after disal gastrectomy
Title of the study (Brief title)	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	Yuichiro Doki
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
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	Yasuhiro Miyazaki
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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