UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501)
Acronym	OGSG-0501
Scientific Title	Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501)
Scientific Title:Acronym	OGSG-0501
Region	Japan

Condition
Condition	distal gastrectomy for gastric cancer
Classification by specialty	Infectious disease Gastrointestinal surgery Operative medicine Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine whether AMP before and during surgical operation has the same effect as AMP administered for 3 to 4 days, postoperatively, by a phase III study on SSI.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Incidence of SSI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: AMP is administered before and during surgical operation and SSI is detected after surgery.
Interventions/Control_2	Group B: AMP is administered before, during and after surgical operation and SSI is detected after surgery.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.age not limmited. 2.histologically proven gastric cancer 3.ASA score of 1 or 2 4.completion of written informed consent 5.distal gastrectomy with D2 lymphadenectomy and clean-contaminated operation
Key exclusion criteria	1.with some active or uncontrolled infection 2.neoadjuvant chemotherapy 3.PS>3 in ASA 4.administration of steroids 5.decision of ineligible patients by the researcher
Target sample size	342

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Imamura
Organization	Toyonaka City Hospital
Division name	Dpt.Surgery
Zip code
Address	4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL	06-6843-0101
Email	imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Imamura
Organization	Toyonaka City Hospital
Division name	Dpt.Surgery
Zip code
Address	4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL	06-6843-0101
Homepage URL
Email	imamurahiroshisakai@yahoo.co.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

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://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70370-X/fulltext
Publication of results	Published

Result
URL related to results and publications	https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70370-X/fulltext
Number of participants that the trial has enrolled	355
Results	Eight patients (5%, 95% CI 2-9%) had surgical-site infections in the intraoperative group compared with 16 (9%, 5-14) in the extended group. The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 0.51 (0.22-1.16), which revealed statistically significant non-inferiority (p<0.0001).
Results date posted	2021 Year 11 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2012 Year 01 Month 31 Day
Baseline Characteristics	Patients with gastric cancer that was potentially curable with a distal gastrectomy
Participant flow	Between June 2, 2005, and Dec 6, 2007, 355 patients were randomly assigned to receive either intraoperative antimicrobial prophylaxis alone (n=176) or extended antimicrobial prophylaxis (n=179).
Adverse events	.
Outcome measures	The primary endpoint was the incidence of surgical-site infections.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date	2005 Year 03 Month 01 Day
Last follow-up date	2008 Year 08 Month 01 Day
Date of closure to data entry	2009 Year 02 Month 01 Day
Date trial data considered complete	2009 Year 02 Month 01 Day
Date analysis concluded	2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 03 Month 07 Day
Last modified on	2021 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000765