Efficacy and Safety of EUS-Guided Therapy Versus BRTO for Gastric Varices With Shunt

Completed

• Conditions: Portal Hypertension; Portosystemic Shunt; Liver Cirrhosis; Gastric Varix
• Interventions: Procedure: balloon-occluded retrograde transvenous obliteration; Procedure: EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

• Registration Number: NCT04828369
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

This study is a retrospective, multi-center and observational clinical study. Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Capital Medical University, The fifth medical center of PLA General Hospital, Zhongshan Hospital, Fudan University, Shanghai, Nanjing Drum Tower Hospital affiliated Nanjing University Medical School and Xiangyang Central Hospital will participate in the study. Investigators would like to provide evidence-based medical evidence by evaluating and comparing the efficacy and safety of endoscopic ultrasound (EUS)-guided coil embolization combined with endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous obliteration (BRTO) in the treatment of gastric varices (GV) with spontaneous portosystemic shunt (SPSS).

Between January 2014 and December 2020, patients with GV secondary to portal hypertension admitted to a tertiary medical center, are enrolled consecutively according to the following criteria: (1) age≥18 years; (2)endoscopic examination confirms the presence of GV; (3) CTA of the portal system and EUS revealed the presence of SPSS, the diameter was between 5 mm to 15 mm; (4) treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO. Exclusion criteria are as follows: (1)malignant tumors; (2) hepatic encephalopathy, hepatorenal syndrome or multiple organ failure; (3) previously received esophagus or stomach surgery; (4) pregnant.

Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until the progress of the disease or the end of the study. And rebleeding, ectopic embolism, survival, and sequential treatment will be recorded during the follow-up period.

The primary endpoint are five-day rebleeding rate and six-week mortality rate. The secondary endpoint are: technical success rate, incidence of ectopic embolism, eradication of GV, one-year rebleeding rate, one-year mortality rate, and cost-effectiveness ratio. All data and information use SPSS statistical software to complete all statistical analysis.

Detailed Description

Because the efficacy and safety of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection and BRTO in the treatment of GV with SPSS have different conclusions in different studies. Investigators based on that the five-day rebleeding rate of EUS-guided coil embolization combined with endoscopic cyanoacrylate injection is 7%, BRTO is 10%. The number of people in the two groups are equal, significant level (α) is 0.05, and the test power is 0.8. Each group requires 35 patients. Because of the 10% loss to follow-up, the sample capacity is 39.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• age≥18 years
• endoscopic examination confirmed the presence of gastric varices
• CTA of the portal system and EUS revealed the presence of spontaneous portosystemic shunt (SPSS) that the diameter was between 5 mm to 15 mm
• treatment with EUS-guided coil combined with endoscopic cyanoacrylate injection or BRTO

Exclusion Criteria

• malignant tumors
• hepatic encephalopathy, hepatorenal syndrome or multiple organ failure
• previously received esophagus or stomach surgery
• pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRTO group	balloon-occluded retrograde transvenous obliteration	Patients who received balloon-occluded retrograde transvenous obliteration (BRTO)
EUS group	EUS-guided coil embolization combined with endoscopic cyanoacrylate injection	Patients who received EUS-guided coil embolization combined with endoscopic cyanoacrylate injection

Primary Outcome Measures

Name	Time	Method
five-day rebleeding rate	5 days after treatment	Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible.
six-week mortality rate	6 weeks after treatment	Patients died in six weeks after treatment due to all causes.

Secondary Outcome Measures

Name	Time	Method
technical success rate	in the procedure of treatment	The coil or balloon was successfully employed and occluded the shunt
eradication of gastric varices	1 year after treatment	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
incidence of ectopic embolism	up to 3 years after treatment	Patients occurred ectopic embolism after treatment confirmed by CTA, ultrasound, etc, with or without clinical manifestation
one-year rebleeding rate	1 year after treatment	Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible
one-year mortality rate	1 year after treatment	Patients died in one year after treatment due to all causes.

Trial Locations

Locations (1)

Mingkai Chen; 🇨🇳 Wuhan, Hubei, China