UMIN-CTR Clinical Trial

Public title

Randomized clinical trial about the period of antimicrobial prophylaxis administration in hepatocellular carcinoma surgery

Acronym

RCT of antimicrobial prophylaxis in hepatocellular carcinoma surgery

Scientific Title

Randomized clinical trial about the period of antimicrobial prophylaxis administration in hepatocellular carcinoma surgery

Scientific Title:Acronym

RCT of antimicrobial prophylaxis in hepatocellular carcinoma surgery

Region

Japan

Condition

Patients undergoing elective hepatocellular carcinoma surgery

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In the U.S.,the National Surgical Infection Prevention Project recommends that prophylactic antibiotics not be extended beyond 24 hours of the end of the operation. On the other hands, most Japanese surgeons use antimicrobial prophylaxis until 3 days of postoperativelly. The optimal duration of antimicrobial prophylaxis has been controversial. The Japan Society for Surgical infection is now conducting a randomized trial to investigate the optimal duration of antimicrobial prophylaxis in hepatocellular carcinoma surgery. This study compared the efficacy of U.S. recommended administration and Japanese common administration for the prevention of surgical site infection in patients undergoing elective rectal cancer surgery. The aim of this study is to establish evidence unique in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome is to show that a 24 hours antibiotic administarion of the end of the operation was not inferior to the 3 days antibiotic administration of the postoperative period .

Key secondary outcomes

The secondary outcome is to investigate the incidence of remote infection in each group.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Flomoxef Sodium is administered afetr the induction of anesthesia, and the patients recieved an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered agin twice daily for 3 concecutive days after the operation

Interventions/Control_2

Flomoxef Sodium is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered at 6 hour and 18hour at end of the oparation.

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Hepatocellular carcinoma patients undergoing liver resection
Liver damage A
ECOG Performance Status Scale:0-2
Written informed consent.

Key exclusion criteria

Laparoscopic surgery
Thoracotomy
Digestive organ or vessel reconstruction
Other organ resection.
Those with cardiac dysfunction, renal dysfunction,
Those who received insulin or steroid therapy.
Those who were allergic to cefem or penicillin, pregnant, received antibiotic treatment in the past 2 weeks, had an infection at the time of surgery.
A woman who is pregnant, lactating, or may become pregnant.
ASA score >3.
Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.

Target sample size

460

Name of lead principal investigator

1st name
Middle name
Last name	Yoshinobu Sumiyama

Organization

Japan Society for Surgical Infection

Division name

The Chief director

Zip code

Address

2-17-6, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan

TEL

03-3481-7316

Email

Name of contact person

1st name
Middle name
Last name	Masato Kusunoki

Organization

Japan Society for Surgical Infection

Division name

Chairman of randomized clinical trial committee

Zip code

Address

2-174, Edobashi, Tsu, Mie, 514-8507, Japan

TEL

059-231-5305

Homepage URL

Email

Institute

Randomized clinical trial committee, Japan Society for Surgical Infection

Institute

Department

Personal name

Organization

Japan Society for Surgical Infection

Organization

Division

Category of Funding Organization

Self funding

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

2009

Year

12

Month

09

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

Completed

Date of protocol fixation

2008

Year

05

Month

19

Day

Date of IRB

Anticipated trial start date

2008

Year

05

Month

01

Day

Last follow-up date

2010

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

12

Month

07

Day

Last modified on

2011

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001419