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

A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices

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

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Varice
• Intervention / Treatment: Procedure: Ligation and Cyanoacrylate; Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Principal Investigator: Shiyao Chen, Professor
      • Contact: Jie Chen, doctor; Phone Number: 86-13764633539; Email: Angelin8716@yahoo.com.cn , 0556289@fudan.edu.cn
      • Sub-Investigator: Jie Chen, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ligation and Cyanoacrylate Group	Procedure: Ligation and Cyanoacrylate; Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
Experimental: Ligation plus Sclerotherapy and Cyanoacrylate Group	Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group; Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate of variceal hemorrhage	recurrence rate of variceal hemorrhage	Participants will be followed for up to 6 months starting from the date of randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication rate of the gastroesophageal varices	We intend to set eradication rate of the gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.	Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
recurrence rate of the gastroesophageal varices	We intend to set recurrence rate of gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.	Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
mortality rate during the follow-up period	mortality rate during the follow-up period	Participants will be followed for up to 6 months starting from the date of randomization.
incidence rate of complications associated with endoscopic treatments	We intend to set incidence rate of complications associated with endoscopic treatments,to be specific,which include trasient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain. Participants will be followed for up to 6 months starting from the date of randomization.	Participants will be followed for up to 6 months starting from the date of randomization.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• Chen J, Zeng XQ, Ma LL, Li B, Tseng YJ, Lian JJ, Gao H, Wang J, Luo TC, Chen SY. Randomized controlled trial comparing endoscopic ligation with or without sclerotherapy for secondary prophylaxis of variceal bleeding. Eur J Gastroenterol Hepatol. 2016 Jan;28(1):95-100. doi: 10.1097/MEG.0000000000000499.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 3, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): April 29, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: portal hypertension; liver cirrhosis; gastroesophgeal variceal bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: CSY-CJ-2012