Clinical trial NCT05515861: Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
Official title: Evaluation of Endoscopic Ultrasound in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Gastric Varix
Portal Hypertension
Keywords: endoscopic ultrasound
gastric varices
rebleeding
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: Southwest Hospital, China
name: Zunyi Medical College
name: Shanxi Coal Center Hospital
First posted: 2022-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Patients are considered eligible when they meet the following criteria: (1) age≥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.

Eligibility criteria: Inclusion Criteria:

* age≥18 years;
* cirrhosis diagnosis is based on liver biopsy, medical history, and physical, biochemical, or radiological findings;
* receive endoscopic cyanoacrylate injection for gastric varices for secondary prophylaxis for the first time;
* patients or a designated relative provide informed consent for the procedures.

Exclusion Criteria:

* with contraindications to endoscopic treatment;
* combined with malignant tumors, hepatic encephalopathy, hepatorenal syndrome, cavernous transformation of the portal vein or multiple organ failure; with spontaneous shunts that the diameter is large than 5 mm;
* previously received endoscopic treatment, interventional treatment or surgical surgery for GV, including transjugular intrahepatic portosystemic shunt (TIPS), balloon-occluded retrograde transvenous obliteration (BRTO), etc;
* pregnant.

Primary outcomes:
measure: Rebleeding
timeFrame: 12 months
Secondary outcomes:
measure: Mortality
timeFrame: 12 months
measure: The eradication rate of gastric varices
timeFrame: 12 months
measure: Calculating the total cost of treatment
timeFrame: 12 months
measure: number of treatment sessions
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen
role: STUDY_DIRECTOR
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