Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Esophageal Varices Clinical Trial

Official title:

Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02740166
• Other study ID #: VGHKS13-CT6-06
• Status: Recruiting
• Phase: Phase 4
• First received: April 12, 2016
• Last updated: April 12, 2016
• Start date: June 2013

Study information

• Verified date: April 2016
• Source: Kaohsiung Veterans General Hospital.
• Contact: Wen-Chi Chen, MD
• Phone: 886-7-3422121
• Email: wcchen[@]vghks.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

Description:

Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age of 20 to 80 years

• Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy

• Stable hemodynamic condition for at least 3 days after banding ligation

Exclusion Criteria:

• Hepatocellular carcinoma or other malignancy

• Stroke or active sepsis

• Chronic kidney disease under renal replacement therapy

• Contraindications to non-selective beta-blockers

• A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery

• Serum total bilirubin >10 mg/dL

• Grade III/IV hepatic encephalopathy

• Refractory ascites

• Hepato-renal syndrome

• Pregnancy

• Severe heart failure (NYHA Fc III/IV)

• Bronchial asthma or chronic obstructive pulmonary disease

• Second or third degree atrioventricular block

• Sick sinus syndrome

• Pacemaker use

• Severe hypotension

• Refusal to participate

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
• Esophageal Varices
• Varicose Veins

Intervention

Drug:
• propranolol
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

de la Peña J, Brullet E, Sanchez-Hernández E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suárez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. — View Citation

Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Bañares R, Albillos A. Meta-analysis: Combination endoscopic and drug therapy to prevent variceal rebleeding in cirrhosis. Ann Intern Med. 2008 Jul 15;149(2):109-22. — View Citation

Kumar A, Jha SK, Sharma P, Dubey S, Tyagi P, Sharma BC, Sarin SK. Addition of propranolol and isosorbide mononitrate to endoscopic variceal ligation does not reduce variceal rebleeding incidence. Gastroenterology. 2009 Sep;137(3):892-901, 901.e1. doi: 10.1053/j.gastro.2009.05.049. Epub 2009 May 27. — View Citation

Lo GH, Lai KH, Cheng JS, Chen MH, Huang HC, Hsu PI, Lin CK. Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: a prospective, randomized trial. Hepatology. 2000 Sep;32(3):461-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent esophageal variceal bleeding	recurrent esophageal variceal bleeding after eradication of esophageal varices	6 years	Yes
Primary	mortality or liver transplantation	mortality or liver transplantation after eradication of esophageal varices	6 years	Yes
Secondary	adverse effects	adverse effects associated with non-selective beta-blockers and banding ligation	6 years	Yes