Preventing Recurrent Bleeding After Eradication of Esophageal Varices

NCT ID: NCT02740166

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30

Brief 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.

Detailed 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.

Conditions

Esophageal Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Banding ligation group

Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Propranolol group

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

Group Type: EXPERIMENTAL

propranolol

Intervention Type: DRUG

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

Interventions

propranolol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: lead

Responsible Party

Wen-Chi Chen

Division of Gastroenterology and Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen-Chi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Locations

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wen-Chi Chen, MD

Role: CONTACT

wcchen@vghks.gov.tw

886-7-3422121 ext. 2139

Facility Contacts

Wen-Chi Chen, MD

Role: primary

wcchen@vghks.gov.tw

+886-7-3422121 ext. 2139

References

Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Banares 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. doi: 10.7326/0003-4819-149-2-200807150-00007.

Reference Type: BACKGROUND

PMID: 18626050 (View on PubMed)

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. doi: 10.1053/jhep.2000.16236.

Reference Type: BACKGROUND

PMID: 10960435 (View on PubMed)

de la Pena J, Brullet E, Sanchez-Hernandez E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suarez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. doi: 10.1002/hep.20584.

Reference Type: BACKGROUND

PMID: 15726659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19481079 (View on PubMed)

Chen WC, Yang TC, Lee PC, Wang YP, Hou MC, Lee FY. A Randomized Controlled Trial of Propranolol Use During Ligation Program for Secondary Prophylaxis of Esophageal Variceal Bleeding. Am J Gastroenterol. 2024 Feb 1;119(2):278-286. doi: 10.14309/ajg.0000000000002457. Epub 2023 Sep 11.

Reference Type: DERIVED

PMID: 37543755 (View on PubMed)

Other Identifiers

VGHKS13-CT6-06

Identifier Type: -

Identifier Source: org_study_id