Clinical trial NCT01592578: The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis
Official title: A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Varice
Keywords: gastroesophgeal variceal bleeding
liver cirrhosis
portal hypertension
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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.

Primary outcomes:
measure: recurrence rate of variceal hemorrhage
timeFrame: Participants will be followed for up to 6 months starting from the date of randomization.
Secondary outcomes:
measure: eradication rate of the gastroesophageal varices
timeFrame: 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.
measure: recurrence rate of the gastroesophageal varices
timeFrame: 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.
measure: mortality rate during the follow-up period
timeFrame: Participants will be followed for up to 6 months starting from the date of randomization.
measure: incidence rate of complications associated with endoscopic treatments
timeFrame: Participants will be followed for up to 6 months starting from the date of randomization.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, professor
role: STUDY_DIRECTOR
References:
citation: 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.