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The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis

Fudan University logo

Fudan University

Status

Unknown

Conditions

Gastroesophageal Varice

Treatments

Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
Procedure: Ligation and Cyanoacrylate

Study type

Interventional

Funder types

Other

Identifiers

NCT01592578
CSY-CJ-2012

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates

Full description

Gastroesophageal variceal bleeding, which often results from portal hypertention, is known as one of the most frequent death causes of patients with liver cirrhosis. When a patient has bleeding episode, it's very likely that he/she will develop another one in the future. Endoscopic treatments such as ligation, sclerotherapy or cyanocrylates are proved to decrease the risk of re-bleeding. The purpose of this study is to evaluate the efficacy of two different endoscopic treatments in patients who have both gastric and esophageal varices with liver cirrhosis: In addition to cyanoacrylates, ligation versus ligation plus sclerotherapy.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 72 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with portal hypertension caused by liver cirrhosis who presented with an acute or recent episode of gastroesophageal variceal bleeding and have previously received endoscopic treatments of ligation and cyanoacrylate. Diagnosis of liver cirrhosis or mixed cirrhosis was based on results of liver biopsy or biochemical tests and liver imaging by ultrasonography.
  • The extent of the varices range from Moderate to Severe.
  • The age of the patients range from 18 to 72 years old.

Exclusion criteria

  • Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
  • Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
  • Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
  • Patients who have previously received shunt or devascularization operation,TIPS.
  • Patients who had portosystemic shunt according to the results of CT scan.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Ligation and Cyanoacrylate Group
Active Comparator group
Treatment:
Procedure: Ligation and Cyanoacrylate
Ligation plus Sclerotherapy and Cyanoacrylate Group
Experimental group
Treatment:
Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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