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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828369
• Other study ID #: 2021F024
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Renmin Hospital of Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varix
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension
• Portosystemic Shunt
• Varicose Veins

Intervention

Procedure:
• EUS-guided coil embolization combined with endoscopic cyanoacrylate injection
(1) Standard diagnostic endoscopy was first performed. Fundal varices were assessed using the classification of Sarin's. (2) intraluminal water filling of the gastric fundus to use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. (3) Punctured the gastric fundal variceal vein at the lower esophagus near the cardia and placed the coil into the shunt and immediately injected with sclerosant and cyanoacrylate under the guidance of EUS. (4) Sclerosant and cyanoacrylate were injected into the gastric fundal varices by a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. (5) After the injection, use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.
• balloon-occluded retrograde transvenous obliteration
(1)A balloon occlusive catheter was inserted into the shunt via the right femoral vein. (2)Investigators performed angiography to evaluate the size and location of GV and the shunt during balloon occlusion. Shunt was occluded by Fogarty balloon. The diameter of the balloon was chosen according to the diameter of shunt. (3)Then investigators injected sclerosant into the portosystemic shunt. (4)Finally, the balloon left in place for 24 hours was gradually deflated when complete occlusion of blood flow of the target shunt was achieved.

Locations

Country	Name	City	State
China	Mingkai Chen	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (8)

Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1. — View Citation

Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):31 — View Citation

Mohan BP, Chandan S, Khan SR, Kassab LL, Trakroo S, Ponnada S, Asokkumar R, Adler DG. Efficacy and safety of endoscopic ultrasound-guided therapy versus direct endoscopic glue injection therapy for gastric varices: systematic review and meta-analysis. End — View 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/s10620-014-34 — View Citation

Qi X, Qi X, Zhang Y, Shao X, Wu C, Wang Y, Wang R, Zhang X, Deng H, Hou F, Li J, Guo X. Prevalence and Clinical Characteristics of Spontaneous Splenorenal Shunt in Liver Cirrhosis: A Retrospective Observational Study Based on Contrast-Enhanced Computed To — View Citation

von Herbay A, Frieling T, Häussinger D. Color Doppler sonographic evaluation of spontaneous portosystemic shunts and inversion of portal venous flow in patients with cirrhosis. J Clin Ultrasound. 2000 Sep;28(7):332-9. — View Citation

Wu Q, Shen L, Chu J, Ma X, Jin B, Meng F, Chen J, Wang Y, Wu L, Han J, Zhang W, Ma W, Wang H, Li H. Characterization of uncommon portosystemic collateral circulations in patients with hepatic cirrhosis. Oncol Lett. 2015 Jan;9(1):347-350. Epub 2014 Oct 22. — View Citation

Zardi EM, Uwechie V, Caccavo D, Pellegrino NM, Cacciapaglia F, Di Matteo F, Dobrina A, Laghi V, Afeltra A. Portosystemic shunts in a large cohort of patients with liver cirrhosis: detection rate and clinical relevance. J Gastroenterol. 2009;44(1):76-83. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	five-day rebleeding rate	Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible.	5 days after treatment
Primary	six-week mortality rate	Patients died in six weeks after treatment due to all causes.	6 weeks after treatment
Secondary	technical success rate	The coil or balloon was successfully employed and occluded the shunt	in the procedure of treatment
Secondary	incidence of ectopic embolism	Patients occurred ectopic embolism after treatment confirmed by CTA, ultrasound, etc, with or without clinical manifestation	up to 3 years after treatment
Secondary	eradication of gastric varices	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	1 year after treatment
Secondary	one-year rebleeding rate	Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy when possible	1 year after treatment
Secondary	one-year mortality rate	Patients died in one year after treatment due to all causes.	1 year after treatment