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

NCT01451658 | Unknown Phase 4 DMC

• 1 other identifier: V99C1-026；V100C-024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Varices Hemorrhage; Hepatocellular Carcinoma

Keywords

Variceal bleeding; portal hypertension; hepatocellular carcinoma; endoscopic variceal ligation; non-selective beta-blocker; rebleeding

Outcome Measures

Primary Outcomes (1)

• Rebleeding

  2 year

Secondary Outcomes (1)

• complication survival

  2 year

Study Arms (2)

EVL or GVS treatment

NO INTERVENTION

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 combined propranolol

EXPERIMENTAL

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

Drug: propranolol

Interventions

propranolol DRUG

Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Also known as: propranolol:Inderal,Cardolol

Endoscopic treatment combined propranolol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of HCC
• endoscopically proven acute variceal bleeding
• younger than 18 years old or older than 80 years old

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Veteran General Hospital-Taipei

Taipei, Ming-Chih Hou, MD, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hypertension, Portal

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 14, 2011
• Study Start: December 1, 2009
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

TW (1)