A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol

NCT01298284 | Unknown Phase 4 DMC

• 2 other identifiers: V99C1-026IRB:98-09-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

New strategy to improve the outcomes in patients with HCC and acute variceal bleeding. NSBB added to endoscopic ligation may further reduce rebleeding in cirrhotic patients.

Conditions

Liver Cirrhosis; Hepatoma

Keywords

Variceal bleeding; portal hypertension; hepatocelluar carcinoma; endoscopic variceal ligation; non-selective beta-blocker; rebleeding

Outcome Measures

Primary Outcomes (1)

• Rebleeding

  1 years

Secondary Outcomes (1)

• complication surivial

  1 years

Study Arms (2)

EVL\GVS Alone

NO INTERVENTION

Endoscopic ligation treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC

EVL\GVS Combined Propranolol

ACTIVE COMPARATOR

Propranolol and endoscopic ligation treatment is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC. \<EVL\\GVS Combined Propranolol\>

Drug: propranolol

Interventions

propranolol DRUG

Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Also known as: Inderal,Cardolol

EVL\GVS Combined Propranolol

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of HCC, endoscopically proven gastroesophageal variceal bleeding
• Aged 18 to 80

You may not qualify if:

• Had a terminal illness of any major organ system,such as heart failure, kidney failure, COPD

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Veteran General Hospital-Taipei

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Hypertension, Portal

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Ming-Chih Hou, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712111; mchou@vghtpe.gov.tw

Han-Chieh Lin, MD

CONTACT

886-2-28712111; hclin@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: February 17, 2011
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

TW (1)