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

NCT ID: NCT01592578

Last Updated: 2013-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Gastroesophageal Varice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ligation and Cyanoacrylate Group

Group Type ACTIVE_COMPARATOR

Ligation and Cyanoacrylate

Intervention Type PROCEDURE

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

Ligation plus Sclerotherapy and Cyanoacrylate Group

Group Type EXPERIMENTAL

Ligation plus Sclerotherapy and Cyanoacrylate Group

Intervention Type PROCEDURE

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

Interventions

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Ligation and Cyanoacrylate

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

Intervention Type PROCEDURE

Ligation plus Sclerotherapy and Cyanoacrylate Group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shiyao Chen

department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyao Chen, professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

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180 Fenglin Road

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Jie Chen, doctor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26517621 (View on PubMed)

Other Identifiers

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CSY-CJ-2012

Identifier Type: -

Identifier Source: org_study_id

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