UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003300 |
|---|---|
| Receipt number | R000002689 |
| Scientific Title | Randomized phase II study of clinical effect of Vessel Sealing System (Ligasure) for open gastrectomy. |
| Date of disclosure of the study information | 2010/03/10 |
| Last modified on | 2010/10/08 11:24:27 |
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Basic information
Public title
Randomized phase II study of clinical effect of Vessel Sealing System (Ligasure) for open gastrectomy.
Acronym
Vessel Sealing System for open gastrectomy
Scientific Title
Randomized phase II study of clinical effect of Vessel Sealing System (Ligasure) for open gastrectomy.
Scientific Title:Acronym
Vessel Sealing System for open gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical superiority of Vessel Sealing System (Ligasure) for operative blood loss of open gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Operative blood loss
Key secondary outcomes
Operative time, postoperative complications, postoperative hospital stay, medical costs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Open gastrectomy with Vessel Sealing System.
Interventions/Control_2
Open gastrectomy without Vessel Sealing System.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Primary treatment for histologically proven adenocarcinoma of the stomach.
2) Indication for open gastrectomy under Guidelines for Diagnosis and Treatment of Carcinoma of the Stomach(Edited by the Japanese Gasric Cancer Society).
3) Clinical stage IA to IIIB by preoperative examinations.
4) Age 20 to 90 years old.
5) Performance status (ECOG) 0 or 1.
6) Written informed consent.
Key exclusion criteria
1) Cancer of gastric remnant.
2) Intention of laparoscopic gastrectomy.
3) Prescribed antiplatelet and anticoagulant agent which needs alternative administration of heparin in the perioperative period.
4) Non curative factors proven by preoperative examinations.
5) Preoperative chemotherapy.
6) Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancer.
7) Metachronous malignancies within 5 years or with tumor recurrence.
8) Severe respiratory dysfunction.
9) History of myocardinal infarction within 6 months before surgery.
10) Liver cirrhosis or active hepatitis.
11) Chronic renal failure with hemodialysis.
12) Uncontrolled diabetes mellitus (HbA1c 9.0 or more).
13) Other unfeasible factors to perform study safely approved by attending surgeon.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, E2, Yamadaoka, Suita, Osaka
TEL
06-6879-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, E2, Yamadaoka, Suita, Osaka
TEL
06-6879-3251
Homepage URL
stakiguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka(MCSGO)
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 10 | 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
Completed
Date of protocol fixation
| 2008 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 08 | Day |
Last modified on
| 2010 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002689
