NCT04074473

Brief Summary

We will include patients with EV and EVB. They will be randomized to EVL vs. NSBB for primary prevention And EVL+long-term NSBB vs. EVL+short-term NSBB for secondary prevention. 150 patients will be included in a 3-year period. Primary end-points are formation/progression of ascites, acute kidney injury and survival. The other outcomes such as bleeding, rebleeding, infection and other risk factors will be also analyzed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

August 29, 2019

Last Update Submit

September 18, 2019

Conditions

Acute Kidney InjuryCirrhosisEsophageal Varices

Keywords

portal hypertension, esophageal varices, non-selective beta-blocker, acute kidney injury.

Outcome Measures

Primary Outcomes (3)

  • Acute kidney injury

    3 years

  • Heparenal syndrome

    3 years

  • overall survival

    3 years

Secondary Outcomes (2)

  • EV bleeding/rebleeding

    3 years

  • Infection rate

    3 years

Study Arms (4)

Propranolol alone

PLACEBO COMPARATOR

TPropranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate\>55 or systemic blood pressure\>90mmHg)

Drug: propranolol

Esophageal variceal ligation alone

ACTIVE COMPARATOR

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy. After eradication, follow-up endoscopy every 3 months and variceal ligation again if recurrence.

Procedure: Esophageal varice ligation

Esophageal variceal ligation(DC inderal after EV eradication)

EXPERIMENTAL

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

Other: DC propranolol

Propranolol(Keep BB after EV eradication)

NO INTERVENTION

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

Interventions

propranololDRUG

Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate\>55 or systemic blood pressure\>90mmHg)

Propranolol alone
Esophageal varice ligationPROCEDURE

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy

Esophageal variceal ligation alone
DC propranololOTHER

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

Esophageal variceal ligation(DC inderal after EV eradication)

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 20 to 85 years
  • Cirrhotic patients with esophageal varices regardless of bleeding event or not will be enrolled in this study.

You may not qualify if:

  • Terminal stage HCC/ other malignancy/ Stroke or active sepsis/ Chronic kidney disease stage 4 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/ 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/ Severe hypotension/ Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryFibrosisEsophageal and Gastric VaricesHypertension, Portal

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712121mchou@vghtpe.gov.tw

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

August 29, 2019

First Posted

August 30, 2019

Study Start

April 13, 2015

Primary Completion

November 5, 2015

Study Completion

July 30, 2020

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

TW(1)