Liver Cirrhosis Clinical Trial
Official title:
Evaluation of Endoscopic Ultrasound in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
The aim of this study is to explore whether using endoscopic ultrasound (EUS) to assess gastric varices (GV) and giving additional treatment according to the diameter and blood flow of residual after endoscopic cyanoacrylate injection for GV can reduce the rate of GV rebleeding, mortality, the risk of adverse events, and cost-effectiveness. This study is a multicenter prospective, open-label, randomized controlled study, including 5 study centers: Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The Southwest Hospital of Army Medical University, Affiliated Hospital of Zunyi Medical University and Shanxi Coal Center Hospital. The total sample size is 150 patients, with 75 patients in the EUS evaluation group and 75 patients in the control group, respectively. The patients who meet the inclusion and exclusion criteria are randomly assigned to EUS evaluation group and control group by using block randomization. The EUS evaluation group uses EUS to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for GV to evaluate the embolization effect. Endoscopic cyanoacrylate injection is performed again if the diameter of variceal vein is larger than 5 mm and with blood flow signal. After the injection, the blood flow signal is confirmed disappear by EUS. The control group return to the ward after endoscopic cyanoacrylate injection, without EUS evaluation. During the study, the patients are followed up for at least 12 months, and they are requested to return to the hospital for follow-up at 1 month, 3 months, 6 months and 12 months after the treatment, respectively. The data of baseline, treatment, postoperative and follow-up of the two groups are need to collect. The primary outcome of this study is rebleeding rate. Secondary outcomes are eradication rate of GV, mortality rate, retreatment, and cost-effectiveness.
Patients are considered eligible when they meet the following criteria: (1) ageā„18 years; (2) cirrhosis diagnosis is based on liver biopsy, medical history, and physical, biochemical, or radiological findings; (3) receive endoscopic cyanoacrylate injection for GV for secondary prophylaxis for the first time; (4) patients or a designated relative provide informed consent for the procedures. Exclusion criteria are as follows: (1) with contraindications to endoscopic treatment; (2)combine with malignant tumors, hepatic encephalopathy, hepatorenal syndrome, cavernous transformation of the portal vein or multiple organ failure; (3) with spontaneous shunts that the diameter is large than 5 mm; (4)previously received endoscopic treatment, interventional treatment or surgical surgery for GV, including transjugular intrahepatic portosystemic shunt (TIPS), balloon-occluded retrograde transvenous obliteration (BRTO), etc; (5) pregnant. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04533932 -
Endosonographic Shear Wave Elastography for Liver Stiffness
|
||
Not yet recruiting |
NCT06031740 -
A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids
|
N/A | |
Not yet recruiting |
NCT06026267 -
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
|
N/A | |
Not yet recruiting |
NCT06076330 -
Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension
|
N/A | |
Enrolling by invitation |
NCT05055713 -
A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism
|
N/A | |
Recruiting |
NCT04578301 -
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
|
||
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Not yet recruiting |
NCT02710227 -
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
|
N/A | |
Not yet recruiting |
NCT03623360 -
Functional MRI to Determine Severity of Cirrhosis
|
||
Completed |
NCT02917408 -
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
|
||
Active, not recruiting |
NCT02551250 -
Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
|
||
Recruiting |
NCT02239991 -
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
|
N/A | |
Enrolling by invitation |
NCT02256514 -
Open Label Trial of Immunotherapy for Advanced Liver Cancer
|
Phase 2 | |
Terminated |
NCT02311985 -
Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial
|
N/A | |
Terminated |
NCT01937130 -
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
|
Phase 2 | |
Recruiting |
NCT01724697 -
Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT01618890 -
Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding
|
Phase 3 | |
Recruiting |
NCT01728727 -
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT01728688 -
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
Terminated |
NCT01686880 -
Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
|
Phase 2 |