Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02695732
Recruitment Status : Unknown
Verified February 2016 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
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
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

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

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Esophageal and Gastric Varices Drug: Carvedilol Device: endoscopy Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding Comparing Carvedilol and Endoscopic Therapy: A Multicenter Randomized Controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

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.




Primary Outcome Measures :
  1. Bleeding rate [ Time Frame: through study completion,an average of 18 months ]
    The investigators observe the variceal bleeding events during the study


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695732


Contacts
Layout table for location contacts
Contact: Shiyao Chen, Professor 86-13601767310 chen.shiyao@zs-hospital.sh.cn

Locations
Layout table for location information
China
Zhongshan Hospital Recruiting
Shanghai, China
Contact: Chu Liu, doctor    86-15201928343    09301010159@fudan.edu.cn   
Principal Investigator: Shiyao Chen, professor         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
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
Investigators
Layout table for investigator information
Study Director: Shiyao Chen, Professor Shanghai Zhongshan Hospital

Layout table for additonal information
Responsible Party: Shiyao Chen, Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02695732     History of Changes
Other Study ID Numbers: CSY-LC02-2016
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
Esophageal and Gastric Varices
Primary Prophylaxis
Carvedilol
Endoscopy

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Esophageal and Gastric Varices
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists