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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01970748
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01970748     History of Changes
Other Study ID Numbers: V101C-016;V102C-094
Study First Received: October 22, 2013
Last Updated: October 22, 2013
Health Authority: Taiwan: Department of Health

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:
Esophageal and Gastric Varices
Varicose Veins
Carcinoma
Hemorrhage
Gastrointestinal Hemorrhage
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 22, 2014