The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver 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 May 2012 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Shiyao Chen, Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT01592578

First received: May 1, 2012

Last updated: April 25, 2013

Last verified: May 2012

History of Changes

Purpose

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

Condition	Intervention
Gastroesophageal Varice	Procedure: Ligation and Cyanoacrylate Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Varicose Veins

U.S. FDA Resources

Further study details as provided by Shiyao Chen, Shanghai Zhongshan Hospital:

Primary Outcome Measures:

recurrence rate of variceal hemorrhage [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]
recurrence rate of variceal hemorrhage

Secondary Outcome Measures:

eradication rate of the gastroesophageal varices [ Time Frame: 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. ]
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.
recurrence rate of the gastroesophageal varices [ Time Frame: 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. ]
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.
mortality rate during the follow-up period [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]
mortality rate during the follow-up period
incidence rate of complications associated with endoscopic treatments [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]
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.


Estimated Enrollment:	96
Study Start Date:	March 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 72 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592578

Locations


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

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators


Study Director:	Shiyao Chen, professor	Shanghai Zhongshan Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Shiyao Chen, department of Gastroenterology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:	NCT01592578 History of Changes
Other Study ID Numbers:	CSY-CJ-2012
Study First Received:	May 1, 2012
Last Updated:	April 25, 2013

Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:


gastroesophgeal variceal bleeding liver cirrhosis portal hypertension

Additional relevant MeSH terms:


Liver Cirrhosis Liver Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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