Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With Hepatocellular Carcinoma
Recruitment status was Recruiting
Patients with hepatocellular carcinoma and esophageal varices bleeding were randomized to undergo endoscopic ligation alone (group A) and additive propranolol treatment (group B) after stabilization of their first acute bleeding.
Gastroesophageal Varices Hemorrhage
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- Rebleeding [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- complication survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||October 2012|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
No Intervention: EVL or GVS treatment
Endoscopic treatment alone is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.
endoscopic variceal ligation (EVL) or Gastric Variceal Sclerotherapy (GVS)
No Intervention: Endoscopic treatment alone versus combined propranolol
Endoscopic treatment alone versus combined propranolol is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
Other Name: propranolol:Inderal,Cardolol
Esophageal variceal bleeding is characteristic of high rebleeding rate and mortality. Thanks to the recent advance of treatment for variceal bleeding such as non-selective beta blocker (NSBB) added to endoscopic ligation further reduce rebleeding in cirrhotic patients, the rebleeding rate and mortality has a marked reduction. However, hepatocellular carcinoma (HCC) is a distinct group characteristic of very poor prognosis in patients with portal hypertension when compared to those of liver cirrhosis only. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451658
|Veteran General Hospital-Taipei||Recruiting|
|Taipei, Ming-Chih Hou, MD, Taiwan, 11217|
|Contact: Ming Chih Hou, MD 886-2-28712121 ext 3763 firstname.lastname@example.org|
|Principal Investigator: Ming Chih Hou, MD|