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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
Scientific title
A Prospective Multi-centre Randomized Trial Comparing Survival between Endoscopic Submucosal Dissection(ESD) and Laparotomy for Early Stage Gastric Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastric cancer 4601 0
Condition category
Condition code
Cancer 4897 4897 0 0
Stomach

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4365 0
Treatment: Surgery
Intervention code [2] 236922 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 5748 0
Survival rate :1,2 , 3 years after treatment.
This outcom will be assessed by health care professionals through telephones or by letters.
Timepoint [1] 5748 0
participants will be followed up once each year for 3 years after ESD or surgery through out the study.
Secondary outcome [1] 241697 0
Complication rate.
This outcome will be assessed through monitoring by health care professionals .
Timepoint [1] 241697 0
at 1month and 1 year after treatment
Secondary outcome [2] 241698 0
Complete ressection rate assessed through monitoring by health care professionals .
Timepoint [2] 241698 0
at 7 days after treatment
Secondary outcome [3] 241699 0
Quality of life(QOL) assessed by questionnaires.
Timepoint [3] 241699 0
at 1month and 1 year after treatment
Secondary outcome [4] 241700 0
average length of stay assessed by hospital records.
Timepoint [4] 241700 0
at discharge (post-initial intervention).

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).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1727 0
China
State/province [1] 1727 0
Beijing

Funding & Sponsors
Funding source category [1] 4785 0
Self funded/Unfunded
Name [1] 4785 0
Country [1] 4785 0
China
Primary sponsor type
Individual
Name
Linghu Enqiang
Address
28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese People's Liberation Army(PLA) general hospital
Country
China
Secondary sponsor category [1] 4321 0
Individual
Name [1] 4321 0
Chen Lin
Address [1] 4321 0
28 Fuxing Road,Beijing,100853,China.
General surgery dept.
Chinese People's Liberation Army(PLA) general hospital
Country [1] 4321 0
China
Other collaborator category [1] 760 0
Individual
Name [1] 760 0
Zhou Pinghong
Address [1] 760 0
180 Fenglin Road,Shanghai,200032,China.
digestive endoscopic centre.
Zhongshan Hospital Fudan University
Country [1] 760 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6834 0
Institute Ethics Committee,Chinese People's Liberation Army (PLA) general hospital
Ethics committee address [1] 6834 0
Ethics committee country [1] 6834 0
China
Date submitted for ethics approval [1] 6834 0
16/04/2009
Approval date [1] 6834 0
01/07/2009
Ethics approval number [1] 6834 0
20090701-11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29492 0
Address 29492 0
Country 29492 0
Phone 29492 0
Fax 29492 0
Email 29492 0
Contact person for public queries
Name 12739 0
Linghu Enqiang
Address 12739 0
28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese PLA general hospital
Country 12739 0
China
Phone 12739 0
+86 10 6818 2255
Fax 12739 0
+86 10 6815 4653
Email 12739 0
linghuenqiang@vip.sina.com
Contact person for scientific queries
Name 3667 0
Linghu Enqiang
Address 3667 0
28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese PLA general hospital
Country 3667 0
China
Phone 3667 0
+86 10 6818 2255
Fax 3667 0
+86 10 6815 4653
Email 3667 0
linghuenqiang@vip.sina.com

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.