Clinical trial NCT04828369: Efficacy and Safety of EUS-Guided Therapy Versus BRTO for Gastric Varices With Shunt
Official title: Efficacy and Safety of EUS-Guided Coil Embolization Combined With Endoscopic Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration for Gastric Varices With High-risk Ectopic Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Liver Cirrhosis
Gastric Varix
Portosystemic Shunt
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in this study are patients with gastric varices resulted from portal hypertension. And the presence of spontaneous portosystemic shunt has been confirmed by CTA or EUS.

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.

Eligibility criteria: 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

Primary outcomes:
measure: five-day rebleeding rate
timeFrame: 5 days after treatment
measure: six-week mortality rate
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: technical success rate
timeFrame: in the procedure of treatment
measure: incidence of ectopic embolism
timeFrame: up to 3 years after treatment
measure: eradication of gastric varices
timeFrame: 1 year after treatment
measure: one-year rebleeding rate
timeFrame: 1 year after treatment
measure: one-year mortality rate
timeFrame: 1 year after treatment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Mingkai Chen
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, PHD
role: STUDY_DIRECTOR
References:
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citation: Park JK, Saab S, Kee ST, Busuttil RW, Kim HJ, Durazo F, Cho SK, Lee EW. Balloon-Occluded Retrograde Transvenous Obliteration (BRTO) for Treatment of Gastric Varices: Review and Meta-Analysis. Dig Dis Sci. 2015 Jun;60(6):1543-53. doi: 10.1007/s10620-014-3485-8. Epub 2014 Dec 18.
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