Clinical Trials Logo
  1. Home
  2. Portal Hypertension
  3. NCT03094234
  4. Details
NCT03094234 Clinical Trial

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

Portal Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03094234
Other study ID # 8mm-TIPS-ChildA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 28, 2017
Est. completion date March 28, 2022

Study information
Verified date November 2021
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 72
Est. completion date March 28, 2022
Est. primary completion date March 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
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.

Locations
Country Name City State
China West china hospital Chengdu

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variceal rebleeding rate Analysis 3 years
Secondary Hepatic encephalopathy rate Analysis 3 years
Secondary TIPS dysfunction rate Analysis 3 years
Secondary The incidence of complications Analysis 3 years
Secondary Mortality rate Analysis 3 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05052892 - A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
Recruiting NCT05251272 - A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
Recruiting NCT05928624 - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Recruiting NCT02364297 - TIPS in Fundal Variceal Bleeding (the TFB Study) N/A
Recruiting NCT01358123 - Value of Von Willebrand Factor in Portal Hypertension N/A
Completed NCT00493480 - Danish Carvedilol Study in Portal Hypertension Phase 3
Recruiting NCT06266260 - Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
Recruiting NCT03277651 - Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension N/A
Active, not recruiting NCT03736265 - Carvedilol for Prevention of Esophageal Varices Progression N/A
Completed NCT03451149 - Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire N/A
Completed NCT02994485 - Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin Phase 4
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Completed NCT01923064 - Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices N/A
Completed NCT01456286 - Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension Phase 2/Phase 3
Completed NCT01551966 - Esophageal Capsule Endoscopy in Children N/A
Completed NCT02344719 - Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis Phase 4
Recruiting NCT00414713 - Transfusion Requirements in Gastrointestinal (GI) Bleeding Phase 4
Completed NCT00766805 - Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis N/A