The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding

February 25, 2016 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial

To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.

Study Type

Interventional

Enrollment (Anticipated)

792

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital
        • Principal Investigator:
          • Shiyao Chen, Professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage
  • a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation

Exclusion Criteria:

  • age greater than 80 years old or younger than 18 years old
  • non-cirrhotic portal hypertension
  • contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on
  • ABPsys less than 95 mmHg or HR less than 50 bpm
  • prior treatment for prevention of bleeding from EGV
  • presence of spontaneous bacterial peritonitis or other severe infections
  • presence of hepatorenal syndrome
  • uncontrolled hepatic encephalopathy
  • presence of refractory ascites
  • pregnancy
  • presence of portosystemic shunt or portal cavernous transformation
  • refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carvedilol
Carvedilol，6.25mg-12.5mg/d,oral,6-36 months
Drug: Carvedilol
Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d.Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm.
Other Names:
  • JinLuo
  • LvDao
Active Comparator: endoscopy
endoscopy，every 4 weeks until eradication of varices
Device: endoscopy
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding rate
Time Frame: through study completion，an average of 18 months
The investigators observe the variceal bleeding events during the study
through study completion，an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: through study completion，an average of 18 months
The investigators observe the mortality events during the study due to variceal bleeding, hepatic encephalopathy, liver failure, hepatic cellular carcinoma, hepatic-renal syndrome and spontaneous bacterial peritonitis.
through study completion，an average of 18 months
Adverse events
Time Frame: through study completion，an average of 18 months
The investigators observe any severe adverse events caused by drug or endoscopic treatment.
through study completion，an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Eastern Hepatobiliary Surgery Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Gongli Hospital, School of Medicine, The Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-LC02-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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