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A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol (S-HCC)

Primary Purpose

Gastroesophageal Varices Hemorrhage, Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
propranolol
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Varices Hemorrhage focused on measuring Variceal bleeding, portal hypertension, hepatocellular carcinoma, endoscopic variceal ligation, non-selective beta-blocker, rebleeding

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veteran General Hospital-TaipeiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

EVL or GVS treatment

Endoscopic treatment combined propranolol

Arm Description

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)

Endoscopic treatment alone versus combined propranolol is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

Outcomes

Primary Outcome Measures

Rebleeding

Secondary Outcome Measures

complication survival

Full Information

First Posted
October 10, 2011
Last Updated
August 29, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01451658
Brief Title
A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol (S-HCC)
Official Title
Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Varices Hemorrhage, Hepatocellular Carcinoma
Keywords
Variceal bleeding, portal hypertension, hepatocellular carcinoma, endoscopic variceal ligation, non-selective beta-blocker, rebleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EVL or GVS treatment
Arm Type
No Intervention
Arm Description
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)
Arm Title
Endoscopic treatment combined propranolol
Arm Type
Experimental
Arm Description
Endoscopic treatment alone versus combined propranolol is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.
Intervention Type
Drug
Intervention Name(s)
propranolol
Other Intervention Name(s)
propranolol:Inderal,Cardolol
Intervention Description
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
Primary Outcome Measure Information:
Title
Rebleeding
Time Frame
2 year
Secondary Outcome Measure Information:
Title
complication survival
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of HCC endoscopically proven acute variceal bleeding 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
Facility Information:
Facility Name
Veteran General Hospital-Taipei
City
Taipei
State/Province
Ming-Chih Hou, MD
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Chih Hou, MD
Phone
886-2-28712121
Ext
3763
Email
mchou@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Ming Chih Hou, MD

12. IPD Sharing Statement

Learn more about this trial

A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol (S-HCC)

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