NCT02638415

Brief Summary

The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.

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
500

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

December 9, 2015

Last Update Submit

December 20, 2015

Conditions

Gastroesophageal VaricesCirrhosis

Keywords

HVPG

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    The investigators observe the mortality events in both groups during the study

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Rebleeding rate

    through study completion, an average of 1 year

  • Adverse Events

    through study completion, an average of 1 year

  • Total cost

    through study completion, an average of 1 year

Study Arms (2)

HVPG group

EXPERIMENTAL

HVPG-guided therapy

Procedure: HVPG-guided therapyDrug: Carvedilol

non-HVPG group

OTHER

routine therapy

Other: routine therapyDrug: Carvedilol

Interventions

HVPG-guided therapyPROCEDURE

Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation. Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication. Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails.

HVPG group
routine therapyOTHER

Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.

non-HVPG group
CarvedilolDRUG

Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications.

HVPG groupnon-HVPG group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices;
  • Patients with a previous history of variceal hemorrhage;
  • Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018

You may not qualify if:

  • Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies;
  • Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival;
  • Patients in pregnancy and lactation;
  • Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors;
  • Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis;
  • Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt;
  • Patients refuse to give consent to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Shiyao Chen, Professor

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of Gastroenterology, Zhongshan Hospital

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 23, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

CN(1)