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8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis

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ClinicalTrials.gov Identifier: NCT03094234
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
luo xuefeng, West China Hospital

Brief Summary:
The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding in patients with Child A cirrhosis

Condition or disease Intervention/treatment Phase
Portal Hypertension Device: 8mm-TIPS Procedure: endoscopic variceal ligation (EVL) Drug: Propranolol Not Applicable

Detailed Description:
For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: 8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : March 28, 2019
Estimated Study Completion Date : March 28, 2020


Arm Intervention/treatment
Active Comparator: 8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Device: 8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.

Active Comparator: EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Procedure: endoscopic variceal ligation (EVL)
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.

Drug: Propranolol
Appropriate dose of propranolol was administered to the patients.




Primary Outcome Measures :
  1. Variceal rebleeding rate [ Time Frame: 3 years ]
    Analysis


Secondary Outcome Measures :
  1. Hepatic encephalopathy rate [ Time Frame: 3 years ]
    Analysis

  2. TIPS dysfunction rate [ Time Frame: 3 years ]
    Analysis

  3. The incidence of complications [ Time Frame: 3 years ]
    Analysis

  4. Mortality rate [ Time Frame: 3 years ]
    Analysis



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -

Exclusion Criteria:

The presence of gastric varices Non-cirrhotic portal hypertension Portal vein thrombosis The history of hepatic encephalopathy Total bilirubin ≥51.3 umol/L Previous treatment of TIPS or surgery Proven malignancy including hepatocellular carcinoma Contraindications to TIPS、EVL or propranolol End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedure

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094234


Locations
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China
West china hospital Recruiting
Chengdu, China
Contact: xuefeng luo    02885422311    luo_xuefeng@yeah.net   
Sponsors and Collaborators
West China Hospital

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Responsible Party: luo xuefeng, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT03094234     History of Changes
Other Study ID Numbers: 8mm-TIPS-ChildA
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Propranolol
Hypertension, Portal
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents