Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000049976
Ethics application status
Not yet submitted
Date submitted
19/11/2010
Date registered
14/01/2011
Date last updated
14/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Randomized Trial Comparing endoscopic LDRf and conventional Type(Japanese taxonomy) for endoscopic therapeutic esophagus variceal.
Scientific title
A Prospective Randomized Trial Comparing Survival between endoscopic LDRf and Conventional Type(Japanese taxonomy) for endoscopic therapeutic esophagus variceal.
Secondary ID [1] 253167 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
esophagus variceal 258686 0
Condition category
Condition code
Oral and Gastrointestinal 258844 258844 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients in the intervention group recieve the endoscopy LDRf type (intervention group)and Japanese type (control group by conventional endoscopy varicosis type)simultaneously to observe patients live rate after EVL therapy.
EVL was performed by a Wilson-Cook 6 rubber bands from the gastroesophageal junction,the first band was released on the varix about 2 cm beyond the bleeding point, then then the second band was released exactly on the bleeding point and the third band was released 2 cm above the bleeding point. EVL takes 0.5-1 hour each session, once every 2 weeks until esophageal varicosis has disappeared.
The LDRf type is considered to be an advanced endoscopic methods for GI variceal. LDRf type characterize it: L:Location;D:Diameter;Rf :Risk factor;The therapeutic method are decided by Location and Diameter; The therapeutic occasion is decided by Risk factor.Japanese type is a conventional type.
Because LDRf type can decrease the risk after esophagus variceals therapy (e.g. rebleeding,mortality,degree of varices; etc).
Intervention code [1] 257861 0
Treatment: Other
Comparator / control treatment
Endoscopic variceal ligation (EVL) was performed in control treatment,;EVL (six-band ligator from W ilson-cook) is once every 2 weeks until esophageal varicosis has disappeared.
Control group
Active

Outcomes
Primary outcome [1] 259693 0
Complication rate. This outcome will be assessed through monitoring by health care professionals .
Timepoint [1] 259693 0
at 1month,3moth,6month and 1 year after treatment
Primary outcome [2] 259720 0
Survival rate :1,2 years after treatment. This outcom will be assessed by health care professionals through telephones or by letters.
Timepoint [2] 259720 0
participants will be followed up once each year for one and half years after EVL,EVS ,EVL+EVS therapy by two kind of endoscopic type method(LDRf type and conventional type).
Primary outcome [3] 259721 0
esophagus variceal remote recur by gastroscopy examination.
Timepoint [3] 259721 0
at 1 year after treatment
Secondary outcome [1] 266390 0
esophagus variceal diferent rates of eradication assessed through monitoring by health care professionals .
Timepoint [1] 266390 0
at 7 days ,1month,3moth,6month and 1 year after treatment
Secondary outcome [2] 266452 0
The diferent rates of rebleeding of EV (esophagus variceal)assessed by health care professionals .
Timepoint [2] 266452 0
at 72 hours,1month,3moth,6month and 1 year after treatment
Secondary outcome [3] 266453 0
average length of stay assessed by hospital records.
Timepoint [3] 266453 0
at discharge (post-initial intervention).

Eligibility
Key inclusion criteria
esophagus variceal diagnosed by two kind of endoscopic type method (LDRf type and conventional type)simultaneity .
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.remote recurrence by gastroscopy examination.
2. after treatment of EVL for EV repeated gastroscopy examination in the same patients.

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: LDRf type and conventional type. 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3058 0
China
State/province [1] 3058 0

Funding & Sponsors
Funding source category [1] 258108 0
Self funded/Unfunded
Name [1] 258108 0
Country [1] 258108 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] 257287 0
None
Name [1] 257287 0
Address [1] 257287 0
Country [1] 257287 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260093 0
Institute Ethics Committee,Chinese People's Liberation Army (PLA) general hospital
Ethics committee address [1] 260093 0
28 Fuxing Road,Beijing,100853,China. Ethics Committee,Chinese PLA general hospital.
Ethics committee country [1] 260093 0
China
Date submitted for ethics approval [1] 260093 0
01/11/2010
Approval date [1] 260093 0
01/11/2010
Ethics approval number [1] 260093 0

Summary
Brief summary
Many articles have showed that LDRf is a safe and effective alternative type for endoscopic esophagus variceal. But there is still no one,which is prospectively randomized and controlled , to compare LDRf type and conventional type for EV.So our purpose is to compare LDRf type and conventional type for EV in a prospectively randomized and controlled way.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31936 0
Address 31936 0
Country 31936 0
Phone 31936 0
Fax 31936 0
Email 31936 0
Contact person for public queries
Name 15183 0
Linghu Enqiang
Address 15183 0
28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese PLA general hospital
Country 15183 0
China
Phone 15183 0
+86 10 6818 2255
Fax 15183 0
+86 10 6815 4653
Email 15183 0
[email protected]
Contact person for scientific queries
Name 6111 0
Linghu Enqiang
Address 6111 0
28 Fuxing Road,Beijing,100853,China.
digestive endoscopic centre
gastroenterologic and hepatologic dept.
Chinese PLA general hospital
Country 6111 0
China
Phone 6111 0
+86 10 6818 2255
Fax 6111 0
+86 10 6815 4653
Email 6111 0
[email protected]

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
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