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Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Primary Purpose

Esophageal Varices

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

About this trial

This is an interventional treatment trial for Esophageal Varices focused on measuring Esophageal Varices; propranolol; banding ligation

Eligibility Criteria

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

Inclusion Criteria:

  • Age of 20 to 80 years
  • Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
  • Stable hemodynamic condition for at least 3 days after banding ligation

Exclusion Criteria:

  • Hepatocellular carcinoma or other malignancy
  • Stroke or active sepsis
  • Chronic kidney disease under renal replacement therapy
  • Contraindications to non-selective beta-blockers
  • A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
  • Serum total bilirubin >10 mg/dL
  • Grade III/IV hepatic encephalopathy
  • Refractory ascites
  • Hepato-renal syndrome
  • Pregnancy
  • Severe heart failure (NYHA Fc III/IV)
  • Bronchial asthma or chronic obstructive pulmonary disease
  • Second or third degree atrioventricular block
  • Sick sinus syndrome
  • Pacemaker use
  • Severe hypotension
  • Refusal to participate

Sites / Locations

  • Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Banding ligation group

Propranolol group

Arm Description

Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.

Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.

Outcomes

Primary Outcome Measures

recurrent esophageal variceal bleeding
recurrent esophageal variceal bleeding after eradication of esophageal varices
mortality or liver transplantation
mortality or liver transplantation after eradication of esophageal varices

Secondary Outcome Measures

adverse effects
adverse effects associated with non-selective beta-blockers and banding ligation

Full Information

First Posted
April 12, 2016
Last Updated
April 12, 2016
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT02740166
Brief Title
Preventing Recurrent Bleeding After Eradication of Esophageal Varices
Official Title
Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.
Detailed Description
Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices
Keywords
Esophageal Varices; propranolol; banding ligation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Banding ligation group
Arm Type
No Intervention
Arm Description
Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.
Arm Title
Propranolol group
Arm Type
Experimental
Arm Description
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Description
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
Primary Outcome Measure Information:
Title
recurrent esophageal variceal bleeding
Description
recurrent esophageal variceal bleeding after eradication of esophageal varices
Time Frame
6 years
Title
mortality or liver transplantation
Description
mortality or liver transplantation after eradication of esophageal varices
Time Frame
6 years
Secondary Outcome Measure Information:
Title
adverse effects
Description
adverse effects associated with non-selective beta-blockers and banding ligation
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 20 to 80 years Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy Stable hemodynamic condition for at least 3 days after banding ligation Exclusion Criteria: Hepatocellular carcinoma or other malignancy Stroke or active sepsis Chronic kidney disease under renal replacement therapy Contraindications to non-selective beta-blockers A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery Serum total bilirubin >10 mg/dL Grade III/IV hepatic encephalopathy Refractory ascites Hepato-renal syndrome Pregnancy Severe heart failure (NYHA Fc III/IV) Bronchial asthma or chronic obstructive pulmonary disease Second or third degree atrioventricular block Sick sinus syndrome Pacemaker use Severe hypotension Refusal to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Chi Chen, MD
Phone
886-7-3422121
Ext
2139
Email
wcchen@vghks.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chi Chen, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Chi Chen, MD
Phone
+886-7-3422121
Ext
2139
Email
wcchen@vghks.gov.tw
First Name & Middle Initial & Last Name & Degree
Wen-Chi Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
18626050
Citation
Gonzalez R, Zamora J, Gomez-Camarero J, Molinero LM, Banares R, Albillos A. Meta-analysis: Combination endoscopic and drug therapy to prevent variceal rebleeding in cirrhosis. Ann Intern Med. 2008 Jul 15;149(2):109-22. doi: 10.7326/0003-4819-149-2-200807150-00007.
Results Reference
background
PubMed Identifier
10960435
Citation
Lo GH, Lai KH, Cheng JS, Chen MH, Huang HC, Hsu PI, Lin CK. Endoscopic variceal ligation plus nadolol and sucralfate compared with ligation alone for the prevention of variceal rebleeding: a prospective, randomized trial. Hepatology. 2000 Sep;32(3):461-5. doi: 10.1053/jhep.2000.16236.
Results Reference
background
PubMed Identifier
15726659
Citation
de la Pena J, Brullet E, Sanchez-Hernandez E, Rivero M, Vergara M, Martin-Lorente JL, Garcia Suarez C. Variceal ligation plus nadolol compared with ligation for prophylaxis of variceal rebleeding: a multicenter trial. Hepatology. 2005 Mar;41(3):572-8. doi: 10.1002/hep.20584.
Results Reference
background
PubMed Identifier
19481079
Citation
Kumar A, Jha SK, Sharma P, Dubey S, Tyagi P, Sharma BC, Sarin SK. Addition of propranolol and isosorbide mononitrate to endoscopic variceal ligation does not reduce variceal rebleeding incidence. Gastroenterology. 2009 Sep;137(3):892-901, 901.e1. doi: 10.1053/j.gastro.2009.05.049. Epub 2009 May 27.
Results Reference
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Preventing Recurrent Bleeding After Eradication of Esophageal Varices

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