UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000648
Receipt number R000000782
Scientific Title A phase III study on the anti-SSI effects of preoperative immunonutrition for patients who undergo total gastrectomy for gastric cancer
Date of disclosure of the study information 2007/04/01
Last modified on 2021/11/15 22:17:58

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Basic information

Public title

A phase III study on the anti-SSI effects of preoperative immunonutrition for patients who undergo total gastrectomy for gastric cancer (OGSG 0507)

Acronym

OGSG 0507

Scientific Title

A phase III study on the anti-SSI effects of preoperative immunonutrition for patients who undergo total gastrectomy for gastric cancer

Scientific Title:Acronym

OGSG 0507

Region

Japan


Condition

Condition

Patients who undergo total gastrectomy for gastric cancer

Classification by specialty

Medicine in general Gastroenterology Infectious disease
Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effects of preoperative immunonutrient(Impact) for the patients who undergo total gastrectomy for gastric cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

primary endpoint
incidence of SSI
secondary endpoints
incidence of infection
postoperative CRP
postoperative complications

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

Group A: Inpact + free food intake
Inpact 1000ml/day during preoperative 5 days and
free food intake
remorize about Inpact intake and administration of
antibiotics

Interventions/Control_2

Group B: Free food intake
without any administration of Inpact
memorize the administration of antibiotics

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. gastric cancer confirmed by endoscopy and histology
2. required the total gastrectomy
3. with a scheduled day for surgical operation
4. patient who can take the immunonutrient for preoperative 5 days
5. without severe weight loss (within -10%)
6. with sufficient function on the liver, kidney and bone marrow
7. age 20<= and 80>=
8. written informed consent

Key exclusion criteria

1. with other severe diseases
2. with some obstruction and/or bleeding on digestive tract
3. with active infectious diseases
4. patient who needs emergent operation
5. patient under some organ failure
6. uncontrolled DM or insulin controlled DM
7. without agreement of doctor

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsujinaka Toshimasa

Organization

National Hospital Organization
Osaka Medical Center

Division name

Dpt.Surgery

Zip code


Address

2-1-14,Houenzaka,Chuou-ku,Osaka,569-0801

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Furukawa Hiroshi

Organization

Sakai City Hospital

Division name

Director

Zip code


Address

1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064

TEL

0722-21-1700

Homepage URL


Email

hfuruk@pop07.oden.ne.jp


Sponsor or person

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name



Funding Source

Organization

Osaka Clinical Study Supporting Organization

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


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

2007 Year 04 Month 01 Day


Related information

URL releasing protocol

https://academic.oup.com/bjs/article/99/5/621/6141011

Publication of results

Published


Result

URL related to results and publications

https://academic.oup.com/bjs/article/99/5/621/6141011

Number of participants that the trial has enrolled

244

Results

Surgical-site infections (SSI) occurred in 27 patients in the immunonutrition group and 23 patients in the control group (risk ratio (RR) 1.09, 95% confidence interval 0.66 to 1.78).

Results date posted

2021 Year 11 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2012 Year 02 Month 24 Day

Baseline Characteristics

patients with primary gastric cancer, fit for total gastrectomy

Participant flow

Of 244 randomized patients, 117 were allocated to the control group and 127 received immunonutrition.

Adverse events

.

Outcome measures

The primary endpoint was the incidence of surgical-site infection (SSI). Secondary endpoints were rates of infectious complications, overall postoperative morbidity, and C-reactive protein (CRP) levels on 3-4 days after surgery.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2005 Year 10 Month 18 Day

Date of IRB


Anticipated trial start date

2005 Year 11 Month 01 Day

Last follow-up date

2008 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 03 Month 22 Day

Last modified on

2021 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000782


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name