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

Primary Purpose

Gastroesophageal Varice

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ligation and Cyanoacrylate

Ligation plus Sclerotherapy and Cyanoacrylate Group

About this trial

This is an interventional treatment trial for Gastroesophageal Varice focused on measuring gastroesophgeal variceal bleeding, liver cirrhosis, portal hypertension

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ligation and Cyanoacrylate Group

Ligation plus Sclerotherapy and Cyanoacrylate Group

Arm Description

Outcomes

Primary Outcome Measures

recurrence rate of variceal hemorrhage

Secondary Outcome Measures

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.

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.

mortality rate during the follow-up period

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.

Full Information

NCT ID

NCT01592578

First Posted

May 1, 2012

Last Updated

April 25, 2013

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01592578

Brief Title

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

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Varice

Keywords

gastroesophgeal variceal bleeding, liver cirrhosis, portal hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ligation and Cyanoacrylate Group

Arm Type

Active Comparator

Arm Title

Ligation plus Sclerotherapy and Cyanoacrylate Group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Ligation and Cyanoacrylate

Intervention Description

Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.

Intervention Type

Procedure

Intervention Name(s)

Ligation plus Sclerotherapy and Cyanoacrylate Group

Intervention Description

Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary

Primary Outcome Measure Information:

Title

recurrence rate of variceal hemorrhage

Description

recurrence rate of variceal hemorrhage

Time Frame

Participants will be followed for up to 6 months starting from the date of randomization.

Secondary Outcome Measure Information:

Title

eradication rate of the gastroesophageal varices

Description

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.

Title

recurrence rate of the gastroesophageal varices

Description

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.

Title

mortality rate during the follow-up period

Description

mortality rate during the follow-up period

Time Frame

Participants will be followed for up to 6 months starting from the date of randomization.

Title

incidence rate of complications associated with endoscopic treatments

Description

Time Frame

Participants will be followed for up to 6 months starting from the date of randomization.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shiyao Chen, professor

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Study Director

Facility Information:

Facility Name

180 Fenglin Road

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Chen, doctor

Phone

86-13764633539

Angelin8716@yahoo.com.cn , 0556289@fudan.edu.cn

First Name & Middle Initial & Last Name & Degree

Shiyao Chen, Professor

First Name & Middle Initial & Last Name & Degree

Jie Chen, doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

26517621

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.

Results Reference

derived

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

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