UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003303
Receipt number 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 20:59:48

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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 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


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

Value
https://center6.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