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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05515861
• Other study ID #: WDRY2022-K042
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: June 2024

Study information

• Verified date: August 2022
• Source: Renmin Hospital of Wuhan University
• Contact: Mingkai Chen
• Phone: +8613720330580
• Email: kaimingchen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (5)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University	Beijing Friendship Hospital, Shanxi Coal Center Hospital, Southwest Hospital, China, Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (16)

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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

Henry Z, Patel K, Patton H, Saad W. AGA Clinical Practice Update on Management of Bleeding Gastric Varices: Expert Review. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-1107.e1. doi: 10.1016/j.cgh.2021.01.027. Epub 2021 Jan 22. Review. — View Citation

Huang YH, Yeh HZ, Chen GH, Chang CS, Wu CY, Poon SK, Lien HC, Yang SS. Endoscopic treatment of bleeding gastric varices by N-butyl-2-cyanoacrylate (Histoacryl) injection: long-term efficacy and safety. Gastrointest Endosc. 2000 Aug;52(2):160-7. — View Citation

Hung HH, Chang CJ, Hou MC, Liao WC, Chan CC, Huang HC, Lin HC, Lee FY, Lee SD. Efficacy of non-selective ß-blockers as adjunct to endoscopic prophylactic treatment for gastric variceal bleeding: a randomized controlled trial. J Hepatol. 2012 May;56(5):102 — View Citation

Iwase H, Suga S, Morise K, Kuroiwa A, Yamaguchi T, Horiuchi Y. Color Doppler endoscopic ultrasonography for the evaluation of gastric varices and endoscopic obliteration with cyanoacrylate glue. Gastrointest Endosc. 1995 Feb;41(2):150-4. — View Citation

Kahana LM, Cole FM, Richardson H. Clinical aspects of atypical mycobacterial infection. Can Med Assoc J. 1975 Feb 8;112(3):321-4. — View Citation

Kim T, Shijo H, Kokawa H, Tokumitsu H, Kubara K, Ota K, Akiyoshi N, Iida T, Yokoyama M, Okumura M. Risk factors for hemorrhage from gastric fundal varices. Hepatology. 1997 Feb;25(2):307-12. — View Citation

Lee YT, Chan FK, Ng EK, Leung VK, Law KB, Yung MY, Chung SC, Sung JJ. EUS-guided injection of cyanoacrylate for bleeding gastric varices. Gastrointest Endosc. 2000 Aug;52(2):168-74. — View Citation

Liao SC, Yang SS, Ko CW, Lien HC, Tung CF, Peng YC, Yeh HZ, Chang CS. A miniature ultrasound probe is useful in reducing rebleeding after endoscopic cyanoacrylate injection for hemorrhagic gastric varices. Scand J Gastroenterol. 2013 Nov;48(11):1347-53. d — View Citation

Lo GH, Lai KH, Cheng JS, Chen MH, Chiang HT. A prospective, randomized trial of butyl cyanoacrylate injection versus band ligation in the management of bleeding gastric varices. Hepatology. 2001 May;33(5):1060-4. — View Citation

Lo GH, Liang HL, Chen WC, Chen MH, Lai KH, Hsu PI, Lin CK, Chan HH, Pan HB. A prospective, randomized controlled trial of transjugular intrahepatic portosystemic shunt versus cyanoacrylate injection in the prevention of gastric variceal rebleeding. Endosc — View Citation

Rajoriya N, Forrest EH, Gray J, Stuart RC, Carter RC, McKay CJ, Gaya DR, Morris AJ, Stanley AJ. Long-term follow-up of endoscopic Histoacryl glue injection for the management of gastric variceal bleeding. QJM. 2011 Jan;104(1):41-7. doi: 10.1093/qjmed/hcq1 — View Citation

Rice JP, Lubner M, Taylor A, Spier BJ, Said A, Lucey MR, Musat A, Reichelderfer M, Pfau PR, Gopal DV. CT portography with gastric variceal volume measurements in the evaluation of endoscopic therapeutic efficacy of tissue adhesive injection into gastric v — View Citation

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding	Rebleeding is defined as recurrent melena or hematemesis and is evaluated via endoscopy whenever possible.	12 months
Secondary	Mortality	Including all-cause mortality.	12 months
Secondary	The eradication rate 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.	12 months
Secondary	Calculating the total cost of treatment	Cost-effectiveness	12 months
Secondary	number of treatment sessions	Cost-effectiveness	12 months