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Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Xijing Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201655
First Posted: September 14, 2010
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fourth Military Medical University
Health Science Center of Xi’an Jiaotong University
Information provided by:
Xijing Hospital
  Purpose
The purpose of this study is to investigate the impact of splenectomy coupled with portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic cirrhosis after hepatitis B or C virus infection by retrospective case-control study,We hope to find a new idear and method to prevent or cure HCC.

Condition
Liver Cirrhosis Carcinoma, Hepatocellular Splenomegaly Laparotomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Multicentric Retrospective Case Control Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Estimated Enrollment: 5000
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:
A case-control study was carried out. The factors studied include age, gender, ascites, hepatic encephalopathy, ALT, AST, TBIL, ALP, GGT, Child-Pugh classification of liver function, and history of splenectomy with portal-azygous disconnection during the treatment of portal hypertension. According to the Child-Pugh classification, these cases were graded as A, B, and C. And according to the ranges of the normal reference values of the data, they were categorized into two groups including a normal group and an abnormal group.The data mainly comes from FMMU and Xi'an jiaotong university from the year of 2002 to 2012.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
post-hepatitic cirrhosis with portal hypertension and hypersplenism patients
Criteria

Inclusion Criteria:

  • after surgery

Exclusion Criteria:

  • without surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201655


Contacts
Contact: Chen yong, professor 13891915509 cheny@fmmu.edu.cn

Locations
China, Shaanxi
Chen yong Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Chen yong, professor    13891915509    cheny@fmmu.edu.cn   
Sub-Investigator: Li zhe, professor         
Sponsors and Collaborators
Xijing Hospital
Fourth Military Medical University
Health Science Center of Xi’an Jiaotong University
Investigators
Study Director: Chen yong, professor Xia jielai
  More Information

Responsible Party: chen yong, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01201655     History of Changes
Other Study ID Numbers: chenyong
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: September 14, 2010
Last Verified: January 2010

Keywords provided by Xijing Hospital:
Posthepatitic cirrhosis;
Hepatocarcinogenesis;
Splenectomy;

Additional relevant MeSH terms:
Splenomegaly
Fibrosis
Liver Cirrhosis
Carcinoma, Hepatocellular
Hypersplenism
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hypertrophy
Pathological Conditions, Anatomical
Splenic Diseases
Lymphatic Diseases