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

Primary Purpose

Liver Cirrhosis, Esophageal and Gastric Varices

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Carvedilol
endoscopy
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Esophageal and Gastric Varices, Primary Prophylaxis, Carvedilol, Endoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carvedilol

endoscopy

Arm Description

Carvedilol，6.25mg-12.5mg/d,oral,6-36 months

endoscopy，every 4 weeks until eradication of varices

Outcomes

Primary Outcome Measures

Bleeding rate
The investigators observe the variceal bleeding events during the study

Secondary Outcome Measures

Mortality rate
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.
Adverse events
The investigators observe any severe adverse events caused by drug or endoscopic treatment.

Full Information

First Posted
February 25, 2016
Last Updated
February 25, 2016
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Gongli Hospital, School of Medicine, The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02695732
Brief Title
The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding
Official Title
Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Gongli Hospital, School of Medicine, The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Esophageal and Gastric Varices
Keywords
Esophageal and Gastric Varices, Primary Prophylaxis, Carvedilol, Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
792 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
Carvedilol，6.25mg-12.5mg/d,oral,6-36 months
Arm Title
endoscopy
Arm Type
Active Comparator
Arm Description
endoscopy，every 4 weeks until eradication of varices
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
JinLuo, LvDao
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
endoscopy
Intervention Description
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.
Primary Outcome Measure Information:
Title
Bleeding rate
Description
The investigators observe the variceal bleeding events during the study
Time Frame
through study completion，an average of 18 months
Secondary Outcome Measure Information:
Title
Mortality rate
Description
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.
Time Frame
through study completion，an average of 18 months
Title
Adverse events
Description
The investigators observe any severe adverse events caused by drug or endoscopic treatment.
Time Frame
through study completion，an average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao Chen, Professor
Phone
86-13601767310
Email
chen.shiyao@zs-hospital.sh.cn
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
Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chu Liu, doctor
Phone
86-15201928343
Email
09301010159@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, professor

12. IPD Sharing Statement

Learn more about this trial

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

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