Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding

NCT02504723 | Completed Phase 4 Results DMC

• 1 other identifier: VGHKS11-CT10-11
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.

Conditions

Esophageal and Gastric Varices

Keywords

Gastric varices; cyanoacrylate; carvedilol

Outcome Measures

Primary Outcomes (1)

• Rebleeding From Gastric Varices

  Rebleeding from gastric varices during the follow-up period

  Within 6 years

Secondary Outcomes (3)

• All Upper Gastrointestinal Bleeding

  Within 6 years

• All Cause Mortality or Liver Transplantation

  Within 6 years

• All Adverse Effects

  Within 6 years

Study Arms (2)

Cyanoacrylate injection plus carvedilol

EXPERIMENTAL

The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.

Drug: carvedilol; Drug: cyanoacrylate

Cyanoacrylate injection

ACTIVE COMPARATOR

The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.

Drug: cyanoacrylate

Interventions

carvedilol DRUG

Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg.

Cyanoacrylate injection plus carvedilol

cyanoacrylate DRUG

The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.

Cyanoacrylate injection; Cyanoacrylate injection plus carvedilol

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 20 to 80 years
• Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
• Stable hemodynamic condition for at least 3 days after cyanoacrylate injection

You may not qualify if:

• Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
• Contraindications to non-selective beta-blockers or cyanoacrylate injection
• Serum total bilirubin \>10 mg/dL
• Grade III/IV hepatic encephalopathy
• Hepato-renal syndrome
• Severe heart failure (NYHA Fc III/IV)
• Chronic kidney disease under renal replacement therapy
• Refractory ascites
• Malignancy other than hepatocellular carcinoma
• Pregnancy
• Pacemaker use
• Refusal to participate

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (1)

• Chen WC, Hsin IF, Chen PH, Hsu PI, Wang YP, Cheng JS, Lin HS, Hou MC, Lee FY. Addition of Carvedilol to Gastric Variceal Obturation Does Not Decrease Recurrence of Gastric Variceal Bleeding in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2356-2363.e2. doi: 10.1016/j.cgh.2019.02.021. Epub 2019 Feb 14.

  PMID: 30772583 DERIVED

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

Carvedilol; Cyanoacrylates

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Acrylates; Acids, Acyclic; Carboxylic Acids; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Wen-Chi Chen
• Organization: Kaohsiung Veterans General Hospital

wcchen@vghks.gov.tw

886-7-3422121

Study Officials

• Wen-Chi Chen, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 18, 2015
• First Posted: July 22, 2015
• Study Start: December 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 21, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-07

Locations

TW (1)