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Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices

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ClinicalTrials.gov Identifier: NCT05515861
Recruitment Status : Not yet recruiting
First Posted : August 25, 2022
Last Update Posted : August 25, 2022
Sponsor:
Collaborators:
Beijing Friendship Hospital
Southwest Hospital, China
Zunyi Medical College
Shanxi Coal Center Hospital
Information provided by (Responsible Party):
ChenMingkai, Renmin Hospital of Wuhan University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Gastric Varix Portal Hypertension Procedure: Endoscopic ultrasound Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Endoscopic Ultrasound in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EUS group
The EUS group uses endoscopic ultrasound to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for gastric varices to evaluate the embolization effect.
 Procedure: Endoscopic ultrasound
Using endoscopic ultrasound (EUS) to observe the diameter and blood flow of residual variceal veins after endoscopic cyanoacrylate injection for gastric varices 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 endoscopic ultrasound. Patients in the EUS group required endoscopic ultrasound assessment at each stage of the follow-up period.
No Intervention: Control group
The control group doesn't perform endoscopic ultrasound after endoscopic cyanoacrylate injection for gastric varices.


Outcome Measures
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Primary Outcome Measures :
  1. Rebleeding [ Time Frame: 12 months ]
    Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy whenever possible.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 12 months ]
    Including all-cause mortality.

  2. The eradication rate of gastric varices [ Time Frame: 12 months ]
    Eradication of the gastric varices is defined as absence of gastric varices on endoscopy or absence of blood flow of gastric varices on endoscopic ultrasound.

  3. Calculating the total cost of treatment [ Time Frame: 12 months ]
    Cost-effectiveness

  4. number of treatment sessions [ Time Frame: 12 months ]
    Cost-effectiveness


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05515861


Contacts
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Contact: Mingkai Chen +8613720330580 kaimingchen@163.com

Locations
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China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Beijing Friendship Hospital
Southwest Hospital, China
Zunyi Medical College
Shanxi Coal Center Hospital
Investigators
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Study Director: Mingkai Chen Renmin Hospital of Wuhan University
More Information
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Publications of Results:

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Responsible Party: ChenMingkai, Professor, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT05515861    
Other Study ID Numbers: WDRY2022-K042
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ChenMingkai, Renmin Hospital of Wuhan University:
endoscopic ultrasound
gastric varices
rebleeding
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Esophageal and Gastric Varices
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
 Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases