Clinical trial NCT02695732: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Esophageal and Gastric Varices
Keywords: Esophageal and Gastric Varices
Primary Prophylaxis
Carvedilol
Endoscopy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Public Health Clinical Center
name: ShuGuang Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Gongli Hospital, School of Medicine, The Second Military Medical University
name: Eastern Hepatobiliary Surgery Hospital
First posted: 2016-03-01
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bleeding rate
timeFrame: through study completion，an average of 18 months
Secondary outcomes:
measure: Mortality rate
timeFrame: through study completion，an average of 18 months
measure: Adverse events
timeFrame: through study completion，an average of 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Professor
role: STUDY_DIRECTOR
References: