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Trial Title:
A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol (S-HCC)
NCT ID:
NCT01451658
Condition:
Gastroesophageal Varices Hemorrhage
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hemorrhage
Propranolol
Conditions: Keywords:
Variceal bleeding
portal hypertension
hepatocellular carcinoma
endoscopic variceal ligation
non-selective beta-blocker
rebleeding
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
propranolol
Description:
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of
baseline, administrated during the whole study period
Arm group label:
Endoscopic treatment combined propranolol
Other name:
propranolol:Inderal,Cardolol
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. clinical diagnosis of HCC
2. endoscopically proven acute variceal bleeding
3. younger than 18 years old or older than 80 years old
Exclusion Criteria:
-Had a terminal illness of any major organ system,such as heart failure, kidney
failure,COPD
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Veteran General Hospital-Taipei
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Ming Chih Hou, MD
Phone:
886-2-28712121
Phone ext:
3763
Email:
mchou@vghtpe.gov.tw
Investigator:
Last name:
Ming Chih Hou, MD
Email:
Principal Investigator
Start date:
December 2009
Completion date:
December 31, 2020
Lead sponsor:
Agency:
Taipei Veterans General Hospital, Taiwan
Agency class:
Other
Source:
Taipei Veterans General Hospital, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01451658
