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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name