UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008616 |
|---|---|
| Receipt number | R000010127 |
| Scientific Title | Prophylactic Impact of Endoscopic treatment for Varices in Liver Resection: A Prospective study |
| Date of disclosure of the study information | 2012/08/10 |
| Last modified on | 2015/02/05 14:20:59 |
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Basic information
Public title
Prophylactic Impact of Endoscopic treatment for Varices in Liver Resection: A Prospective study
Acronym
Prophylactic Impact of Endoscopic treatment for Varices in Liver Resection: A Prospective study
Scientific Title
Prophylactic Impact of Endoscopic treatment for Varices in Liver Resection: A Prospective study
Scientific Title:Acronym
Prophylactic Impact of Endoscopic treatment for Varices in Liver Resection: A Prospective study
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess prospectively the prophylactic impact of esophageal varices in patient with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prophylactic impact for esophageal varices
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria included liver function of Child-Pugh class A or B, curative hepatic resection for hepatocellular carcinoma (HCC) without severe medical comorbidities.
Key exclusion criteria
Exclusion criteria were previous endoscopic, radiological or surgical treatment for esophageal varices. The patients who have a history of esophageal or gastric operation as well as the serious medical conditions that could not be performed repeat endoscopy were excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Yamazaki |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
30-1 Ohyaguchikami-machi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
yamazaki-nmed@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Yamazaki |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
Address
30-1 Ohyaguchikami-machi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
Homepage URL
yamazaki-nmed@umin.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
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
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
| 2012 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative endoscopic screening for esophageal varices and gastroduodenal ulceration was performed in patients with hepatocellular carcinoma who undergoing liver resection. The prophylactic treatment was performed to the high-risk esophageal varices (huge varices: F3 or intermediate: F2 with red color sign positive) and the active-bleeding gastroduodenal ulceration. Follow-up endoscopy was performed to assess the outcomes of these lesions on 1 week, 1 month and 6 month after operation.
Management information
Registered date
| 2012 | Year | 08 | Month | 04 | Day |
Last modified on
| 2015 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010127
