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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003303
Receipt No. R000003993
Scientific Title Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.
Date of disclosure of the study information 2010/03/09
Last modified on 2012/03/09

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Basic information
Public title Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.
Acronym Harmonic scalpel for open gastrectomy.
Scientific Title Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.
Scientific Title:Acronym Harmonic scalpel 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 ultrasonically activated coagulating shears (Harmonic scalpel) for operative time from skin incision to resection of gastric specimen 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 time from skin incision to resection of gastric specimen
Key secondary outcomes total operative time, operative blood loss, 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 ultrasonically activated coagulating shears
Interventions/Control_2 Open gastrectomy without ultrasonically activated coagulating shears
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 230

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, Japan
TEL 06-6879-3251
Email

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, Japan
TEL 06-6879-3251
Homepage URL
Email stakiguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka (MCSGO)
Institute
Department

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
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
2010 Year 03 Month 09 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
2009 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2011 Year 09 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
2010 Year 03 Month 09 Day
Last modified on
2012 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003993

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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