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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02695732
• Other study ID #: CSY-LC02-2016
• Status: Recruiting
• Phase: Phase 4
• First received: February 25, 2016
• Last updated: February 25, 2016
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2016
• Source: Shanghai Zhongshan Hospital
• Contact: Shiyao Chen, Professor
• Phone: 86-13601767310
• Email: chen.shiyao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 792
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Liver Cirrhosis

Intervention

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.

Device:
• endoscopy
Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Eastern Hepatobiliary Surgery Hospital, Gongli Hospital, School of Medicine, The Second Military Medical University, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding rate	The investigators observe the variceal bleeding events during the study	through study completion,an average of 18 months	No
Secondary	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.	through study completion,an average of 18 months	No
Secondary	Adverse events	The investigators observe any severe adverse events caused by drug or endoscopic treatment.	through study completion,an average of 18 months	No