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

NCT05515861 | Unknown

• 1 other identifier: WDRY2022-K042
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Gastric Varix; Portal Hypertension

Keywords

endoscopic ultrasound; gastric varices; rebleeding

Outcome Measures

Primary Outcomes (1)

• Rebleeding

  Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy whenever possible.

  12 months

Secondary Outcomes (4)

• Mortality

  12 months

• The eradication rate of gastric varices

  12 months

• Calculating the total cost of treatment

  12 months

• number of treatment sessions

  12 months

Study Arms (2)

EUS group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group doesn't perform endoscopic ultrasound after endoscopic cyanoacrylate injection for gastric varices.

Interventions

Endoscopic ultrasound PROCEDURE

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.

EUS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Beijing Friendship Hospital: collaborator
• Southwest Hospital, China: collaborator
• Zunyi Medical College: collaborator
• Shanxi Coal Center Hospital: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (16)

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MeSH Terms

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices; Hypertension, Portal

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Mingkai Chen

  Renmin Hospital of Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Mingkai Chen

CONTACT

+8613720330580; kaimingchen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 25, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)