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Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices (P-HCC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970748
First Posted: October 28, 2013
Last Update Posted: October 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
  Purpose
Randomized comparison within the endoscopic esophageal varices ligation versus non-selective beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.

Condition Intervention Phase
Bleeding Esophageal Varices Hepatocellular Carcinoma Drug: Propranolol Procedure: Esophageal variceal ligation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment Versus Propranolol for Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Bleeding [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Complication survival [ Time Frame: 2 years ]

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Propranolol
Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)
Drug: Propranolol
Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)
Other Name: Inderal, Cardolol
Active Comparator: Esophageal variceal ligation
Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy. After eradication, follow-up endoscopy every 3 months and variceal ligation again if recurrence.
Procedure: Esophageal variceal ligation
Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy
Other Name: EVL

Detailed Description:

Gastroesophageal variceal bleeding is a major complication of cirrhosis and has high rate of rebleeding and mortality. In these 20 to 30 years, medical advances have significantly improved the prognosis of variceal bleeding. Nevertheless, the mortality of gastroesophageal variceal bleeding is still nearly 20 to 30%.

Hepatocellular carcinoma (HCC) is one of the most common malignancy in Asian, and is also the special group in portal hypertension. Studies in Italy, more than 50% of patients diagnosed with HCC are concomitant with esophageal varices. HCC and portal thrombosis caused by HCC itself are all independent risk factors of gastroesophageal bleeding. Once the bleeding, rebleeding rate is up to 50% even if early use of vasoconstrictor agents and endoscopic therapy, which is generally 2 times in patients with cirrhosis.

According to 2010 Baveno V recommendations, non-selective beta-blockers (NSBB) or endoscopic variceal ligation (EVL) are first choice for primary prevention of first variceal bleeding in cirrhotic patients. However, risk factors of variceal bleeding caused by HCC or cirrhosis are different, and portal hypertension is particularly high in patients with HCC and may be combined with portal vein thrombosis. NSBB sufficient to decreased portal hypertension to prevent variceal bleeding is not clear. In Hepatology 2010, Lebrec claimed that NSBB used for cirrhotic patients with refractory ascites had poor prognosis, the main cause of death were the progression of HCC and sepsis, although the impact of NSBB for HCC patients are not entirely clear, but this issue remind clinicians to careful use of NSBB in these patients. Since NSBB possible adverse effects, the use of EVL to prevent bleeding in patents with HCC is superior to NSBB? These need further study to clarify. So we designed this study to evaluate the feasibility and effectiveness of using EVL or NSBB to prevent first bleeding in patients with HCC concomitant with esophageal varices.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 20 and 80 years old
  • Hepatocellular carcinoma (HCC) associated with esophageal varices
  • F2 or F3 esophageal varices (Beppu et al classification)
  • Hepatocellular carcinoma (HCC) associated with portal thrombosis

Exclusion Criteria:

  • History of esophageal variceal bleeding
  • Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
  • Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
  • Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970748


Contacts
Contact: Ming-Chih Hou, MD 886-2-28712121 ext 1320 mchou@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Ming-Chih Hou, MD    886-2-28712121 ext 1320    mchou@vghtpe.gov.tw   
Contact: Han-Chieh Lin, MD    886-2-28712121 ext 7506    hclin@vghtpe.gov.tw   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
  More Information

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01970748     History of Changes
Other Study ID Numbers: V101C-016;V102C-094
First Submitted: October 22, 2013
First Posted: October 28, 2013
Last Update Posted: October 28, 2013
Last Verified: October 2013

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Variceal bleeding
Portal hypertension
Hepatocellular carcinoma
Endoscopic variceal ligation
Non-selective beta-blocker

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Hemorrhage
Varicose Veins
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents