UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012152 |
|---|---|
| Receipt number | R000013826 |
| Scientific Title | A randomized phase II study to evaluate the prolonged prophylactic antibacterial drug treatment for patients with elevated drain-amylase concentration after gastrectomy with D2 lymph node dissection |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2017/02/06 23:48:39 |
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Basic information
Public title
A randomized phase II study to evaluate the prolonged prophylactic antibacterial drug treatment for patients with elevated drain-amylase concentration after gastrectomy with D2 lymph node dissection
Acronym
REDUCED2
Scientific Title
A randomized phase II study to evaluate the prolonged prophylactic antibacterial drug treatment for patients with elevated drain-amylase concentration after gastrectomy with D2 lymph node dissection
Scientific Title:Acronym
REDUCED2
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prolonged prophylactic antibacterial drugs for patients with elevated drain-amylase concentration after gastrectomy with D2 lymph node dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prophylactic antibacterial drug only for the operative day
Interventions/Control_2
Prophylactic antibacterial drug until the 7th postoperative day
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) Biopsy specimen from the primary lesion shows adenocarcinoma
2) R0 resection or R1 resection with CY1 by gastrectomy with D2 lymph node dissection
3) The maximum value of drain amylase concentration is above 3000 (IU/L)
4) Esophageal invasion is less than 3cm.
5) Eeatern clinical oncology group performans status is 0 or 1
6) No previous chemotherapy or radiation including those for other cancers
7) Fulfil all following conditions
WBC > 3,000/mm3
Plt > 100,000/mm3
AST < 100 IU/L
ALT < 100IU/L
T.Bil < 2.0 g/dl
Cre < 1.5mg/dl
8) written informed consent
Key exclusion criteria
1) Having other active infectious disease
2) combined resection (gall bladder and spleen are exceptions)
3) Possibly pregnant, or breast feeding woman
4) with psychiatric disorder
5) Receiving steroids
6) With Acute myocardial infaction in 6 months or with unstable ungina
7) With uncontrolled hypertention
8) With uncontrolled diabetes mellitus
9) With pulmonary disease and require continuous oxygen therapy
10) With allergy to cephalosporin
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Terashima |
Organization
Shizuoka Cancer Center
Division name
Gastric Surgery
Zip code
Address
1007, Shimonagakubo, Nagaizumi, Sunto, Shizuoka
TEL
055-989-5222
m.terashima@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Miki |
Organization
Shizuoka Cancer Center
Division name
Gastric Surgery
Zip code
Address
1007, Shizumonagakubo, Naagizumi, Sunto, Shizuoka
TEL
055-989-5222
Homepage URL
y.miki@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛知県がんセンター中央病院消化器外科、岩手医科大学外科学講座、大阪府立急性期総合医療センター外科、国立病院機構大阪医療センター外科、静岡県立静岡がんセンター胃外科、山形県立中央病院外科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Date of protocol fixation
| 2013 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013826
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
