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

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 June 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
Information provided by:
Taipei Veterans General Hospital, Taiwan Identifier:
First received: October 4, 2010
Last updated: June 14, 2011
Last verified: June 2011
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.

Condition Intervention Phase
Liver Cirrhosis
Drug: propranolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With HCC:a Randomized Trial

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Rebleeding [ Time Frame: 1 years ]

Secondary Outcome Measures:
  • complication surivial [ Time Frame: 1 years ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: EVL\GVS Alone
Endoscopic ligation treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC
Active Comparator: EVL\GVS Combined Propranolol

Propranolol and endoscopic ligation treatment is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

<EVL\GVS Combined Propranolol>

Drug: propranolol
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
Other Name: Inderal,Cardolol

Detailed Description:

Gastroesophageal vaiceal bleeding is a major complication of portal hypertension. Gastroesophageal variceal bleeding is characteristic of high rebleeding rate and mortality. Thanks to the recent advance of treatment including immediate vasoactive agents (such as somatostatin and vasopressin analogue for acute bleeding), non-selective beta-blocker (NSBB) for prevention of bleeding, prophylactic antibiotics, endoscopic variceal ligation, endoscopic cyanoacrylate injection , combination treatment and general improvement of care for patients with acute variceal bleeding, the rebleeding rate and mortality has a marked reduction. However, hepatocellular carcinoma (HCC) is a distinct group characteristic of very poor prognosis in patients in portal hypertensive patients when compared to those of liver cirrhosis only. Therefore it needs to specially clarify their treatment strategy, particularly in Taiwan, a highly prevalent area of HCC.

In patients of HCC presenting acute variceal bleeding, the rebleeding is around 50% doubled that of patients with cirrhosis only and bleeding mortality also more than 50%. The trend is not changed even after introduction of immediate use of vasoactive agents and endoscopic ligation. The poor outcome is because that HCC patients usually have arterioporal shunting or portal vein thrombosis and higher portal pressure. Moreover, their liver function deteriorated faster. Both high portal pressure and poor liver function are major determinant of hemostatic outcomes. Therefore, it is important to find a 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. However, whether the hypotensive effect of NSBB is adequate to prevent rebleeding in patients with HCC who usually has higher portal pressure in not known. In addition, concomitant rapid deterioration of liver function might also dampen NSBB effects. Furthermore, due to faster deterioration of general condition, the tolerance of NSBB in these patients might be remarkable and lead to a higher withdrawal rate. Therefore, it is very important to clarify whether there is additive therapeutic effect of NSBB to endoscopic treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

Therefore, the investigators design a study to randomize patients with HCC and acute variceal bleeding to endoscopic treatment alone and combination with endoscopic treatment and NSBB. This is the two years study.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Had a terminal illness of any major organ system,such as heart failure, kidney failure, COPD
  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 identifier: NCT01298284

Contact: Ming-Chih Hou, MD 886-2-28712111 ext 3763
Contact: Han-Chieh Lin, MD 886-2-28712111 ext 3349

Veteran General Hospital-Taipei Recruiting
Taipei city, Taiwan
Contact: Ming-Chih Hou, MD    886-2-28712121 ext 3763   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
  More Information

Responsible Party: MING CHIH HOU,M.D / Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital Identifier: NCT01298284     History of Changes
Other Study ID Numbers: V99C1-026
IRB:98-09-09 ( Other Identifier: IRB:98-09-09 )
Study First Received: October 4, 2010
Last Updated: June 14, 2011

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Variceal bleeding
portal hypertension
hepatocelluar carcinoma
endoscopic variceal ligation
non-selective beta-blocker

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents processed this record on May 25, 2017