Liver Cirrhosis Clinical Trial
Official title:
The Effect of Carvedilol Vs Propranolol in Patients With Cirrhosis Related Esophagogastric Varices After Multiple Endoscopic Treatments For Secondary Prophylaxis:A Randomized Controlled Trial
To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.
Status | Recruiting |
Enrollment | 480 |
Est. completion date | November 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - age between 18-70 years old; - cirrhotic patients referred to Zhongshan Hospital with esophagogastric varices confirmed by endoscopy; - history of variceal bleeding; at least 3 times of endoscopic treatment; - with 1) mild esophageal varices;2) gastric varices with a diameter less than 5mm; or 3) variceal eradication at the time of recruiting. Exclusion Criteria: Patients are excluded when they have - episodes of variceal bleeding after the last endoscopic treatment; - diagnosis of hepatic cellular carcinoma; - severe systemic diseases; - refractory ascites; - contraindication to Carvedilol or Propranolol, such as: asthma, chronic obstructive pulmonary disease, allergic rhinitis, New York Heart Association IV chronic heart failure, atrioventricular blockade, severe bradycardia(HR<50bpm), sick sinus syndrome, cardiogenic shock, severe hypotension(ABPsys<85mmHg); - previous and continued use of ß-blockers; - Child -Pugh Class C. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Shanghai Zhongshan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endoscopic Retreatment | Patients will receive an endoscopic examination after they have been followed up for 6 months, and if they have recurrence of varices or deterioration of varices,they are considered to be in need of endoscopic retreatment. | 6 months | No |
Secondary | Rebleeding rate | We observe the variceal rebleeding events during 6 months. | 6 months | No |
Secondary | Mortality rate | We observe the mortality events during 6 months due to variceal bleeding, hepatic encephalopathy, liver failure, hepatic cellular carcinoma, hepatic-renal syndrome and spontaneous bacterial peritonitis. | 6 months | No |
Secondary | Adverse events | We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia. | 6 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04533932 -
Endosonographic Shear Wave Elastography for Liver Stiffness
|
||
Not yet recruiting |
NCT06031740 -
A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids
|
N/A | |
Not yet recruiting |
NCT06026267 -
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
|
N/A | |
Not yet recruiting |
NCT06076330 -
Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension
|
N/A | |
Enrolling by invitation |
NCT05055713 -
A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism
|
N/A | |
Recruiting |
NCT04578301 -
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
|
||
Not yet recruiting |
NCT05515861 -
Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Not yet recruiting |
NCT03623360 -
Functional MRI to Determine Severity of Cirrhosis
|
||
Not yet recruiting |
NCT02710227 -
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
|
N/A | |
Completed |
NCT02917408 -
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
|
||
Active, not recruiting |
NCT02551250 -
Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
|
||
Recruiting |
NCT02239991 -
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
|
N/A | |
Enrolling by invitation |
NCT02256514 -
Open Label Trial of Immunotherapy for Advanced Liver Cancer
|
Phase 2 | |
Terminated |
NCT02311985 -
Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial
|
N/A | |
Terminated |
NCT01937130 -
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
|
Phase 2 | |
Recruiting |
NCT01618890 -
Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding
|
Phase 3 | |
Recruiting |
NCT01724697 -
Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT01728727 -
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT01728688 -
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 |