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Trial registered on ANZCTR
Registration number
ACTRN12609000754246
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
31/08/2009
Date last updated
31/08/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Prospective Multi-centre Randomized Trial Comparing Endoscopic Submucosal Dissection(ESD) and Laparotomy for Early Stage Gastric Cancer
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Scientific title
A Prospective Multi-centre Randomized Trial Comparing Survival between Endoscopic Submucosal Dissection(ESD) and Laparotomy for Early Stage Gastric Cancer
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
gastric cancer
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Condition category
Condition code
Cancer
4897
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0
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Endoscopic submucosal dissection (ESD) is an advanced technique of therapeutic endoscopy for superficial gastrointestinal neoplasms. Three steps characterize it:injecting fluid (several fluids such as saline, glycerol and hyaluronic acid are usually combined with diluted epinephrine) into the submucosa to elevate the lesion,cutting the surrounding mucosa of the lesion, and dissecting the submucosa beneath the lesion.
The amout of fluid varies according to the size of cancer and the amount is appropriate when the fluid injected can make the cancer safe enough for endoscopists to cut it off.
This is a one-off treatment and the duration of ESD itself often varies from one hour to 3 hours.
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Intervention code [1]
4365
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Treatment: Surgery
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Intervention code [2]
236922
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Treatment: Devices
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Comparator / control treatment
Laparotomy: subtotal gastrectomy.
Laparotomy means a cut in the abdomen in order to perform an operation or an examination.
Gastrectomy means the surgical removal of all or part of the stomach.
Subtotal gastrectomy means the surgical removal of part of the stomach.
This is a one-off treatment and the duration of Laparotomy itself is often varies from 2 hours to 3 hours.
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Control group
Active
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Outcomes
Primary outcome [1]
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Survival rate :1,2 , 3 years after treatment.
This outcom will be assessed by health care professionals through telephones or by letters.
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Assessment method [1]
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Timepoint [1]
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participants will be followed up once each year for 3 years after ESD or surgery through out the study.
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Secondary outcome [1]
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Complication rate.
This outcome will be assessed through monitoring by health care professionals .
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Assessment method [1]
241697
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Timepoint [1]
241697
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at 1month and 1 year after treatment
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Secondary outcome [2]
241698
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Complete ressection rate assessed through monitoring by health care professionals .
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Assessment method [2]
241698
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Timepoint [2]
241698
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at 7 days after treatment
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Secondary outcome [3]
241699
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Quality of life(QOL) assessed by questionnaires.
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Assessment method [3]
241699
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Timepoint [3]
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at 1month and 1 year after treatment
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Secondary outcome [4]
241700
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average length of stay assessed by hospital records.
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Assessment method [4]
241700
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Timepoint [4]
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at discharge (post-initial intervention).
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Eligibility
Key inclusion criteria
1.early gastric cancer diagnosed by both gastroscopy and pathological examination.
2.lesion to be mucosal or submucosal by endoscopic ultrasound( EUS).
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1.remote metastasis by computed tomography(CT),magnetic resonance imaging(MRI) or positron emission tomography (PET).
2.undifferentiated carcinoma,signet-ring cell carcinoma
3.after treatment of endoscopic electrocoagulation,laser,Argon gas,microwave,endoscopic mucosal resection(EMR) or repeated biopsy in the same lesion.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each patient enrolled in the study will be given a serial number and will be randomized in blocks to one of the two groups:esd and surgery.
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
16/07/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
1727
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China
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State/province [1]
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Beijing
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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China
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Primary sponsor type
Individual
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Name
Linghu Enqiang
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Address
28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese People's Liberation Army(PLA) general hospital
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Country
China
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Secondary sponsor category [1]
4321
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Individual
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Name [1]
4321
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Chen Lin
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Address [1]
4321
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28 Fuxing Road,Beijing,100853,China.
General surgery dept.
Chinese People's Liberation Army(PLA) general hospital
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Country [1]
4321
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China
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Other collaborator category [1]
760
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Individual
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Name [1]
760
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Zhou Pinghong
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Address [1]
760
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180 Fenglin Road,Shanghai,200032,China.
digestive endoscopic centre.
Zhongshan Hospital Fudan University
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Country [1]
760
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China
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Institute Ethics Committee,Chinese People's Liberation Army (PLA) general hospital
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Ethics committee address [1]
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28 Fuxing Road,Beijing,100853,China. Ethics Committee,Chinese PLA general hospital.
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Ethics committee country [1]
6834
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China
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Date submitted for ethics approval [1]
6834
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16/04/2009
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Approval date [1]
6834
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01/07/2009
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Ethics approval number [1]
6834
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20090701-11
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Summary
Brief summary
Many articles have suggested that ESD is a safe and effective alternative treatment for early gastric cancer. But there is still no one,which is prospective randomised controlled , to compare ESD and laparotomy for early gastric cancer . So our purpose is to compare esd and laparotomy for early gastric cancer in a prospective randomised controlled way.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
29492
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Contact person for public queries
Name
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Linghu Enqiang
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Address
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28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese PLA general hospital
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Country
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China
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Phone
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+86 10 6818 2255
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Fax
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+86 10 6815 4653
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Email
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[email protected]
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Contact person for scientific queries
Name
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Linghu Enqiang
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Address
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28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese PLA general hospital
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Country
3667
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China
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Phone
3667
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+86 10 6818 2255
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Fax
3667
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+86 10 6815 4653
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Email
3667
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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