UMIN-CTR Clinical Trial

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

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Postoperative serum ghrelin level

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

No important notice

Registered date

2017

Year

07

Month

14

Day

Last modified on

2017

Year

07

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031536