NCT02695732

Brief Summary

To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.

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
792

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Typical duration 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

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

February 25, 2016

Last Update Submit

February 25, 2016

Conditions

Liver CirrhosisEsophageal and Gastric Varices

Keywords

Esophageal and Gastric VaricesPrimary ProphylaxisCarvedilolEndoscopy

Outcome Measures

Primary Outcomes (1)

  • Bleeding rate

    The investigators observe the variceal bleeding events during the study

    through study completion，an average of 18 months

Secondary Outcomes (2)

  • Mortality rate

    through study completion，an average of 18 months

  • Adverse events

    through study completion，an average of 18 months

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol，6.25mg-12.5mg/d,oral,6-36 months

Drug: Carvedilol

endoscopy

ACTIVE COMPARATOR

endoscopy，every 4 weeks until eradication of varices

Device: endoscopy

Interventions

CarvedilolDRUG

Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d.Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm.

Also known as: JinLuo, LvDao
Carvedilol
endoscopyDEVICE

Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.

endoscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage
  • a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation

You may not qualify if:

  • age greater than 80 years old or younger than 18 years old
  • non-cirrhotic portal hypertension
  • contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on
  • ABPsys less than 95 mmHg or HR less than 50 bpm
  • prior treatment for prevention of bleeding from EGV
  • presence of spontaneous bacterial peritonitis or other severe infections
  • presence of hepatorenal syndrome
  • uncontrolled hepatic encephalopathy
  • presence of refractory ascites
  • pregnancy
  • presence of portosystemic shunt or portal cavernous transformation
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisEsophageal and Gastric Varices

Interventions

CarvedilolEndoscopy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesHypertension, Portal

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Shiyao Chen, Professor

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310chen.shiyao@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of Gastroenterology, Zhongshan Hospital

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 1, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

CN(1)