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

October 22, 2013
October 22, 2013
August 2009
December 2013   (final data collection date for primary outcome measure)
Bleeding [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Complication survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices
Endoscopic Treatment Versus Propranolol for Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bleeding Esophageal Varices
  • Hepatocellular Carcinoma
  • 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
  • Procedure: Esophageal variceal ligation
    Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy
    Other Name: EVL
  • 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)
    Intervention: Drug: Propranolol
  • 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.
    Intervention: Procedure: Esophageal variceal ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2013   (final data collection date for primary outcome measure)

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...)
Both
20 Years to 80 Years
No
Contact: Ming-Chih Hou, MD 886-2-28712121 ext 1320 mchou@vghtpe.gov.tw
Taiwan
 
NCT01970748
V101C-016;V102C-094
Yes
Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
Not Provided
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP