EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I

Cirrhosis Clinical Trial

Official title:

EUS-guided Combined Therapy of Coiling and 2-octyl-cyanoacrylate Injection With Beta Blocker Therapy Versus Beta Blocker Alone for the Primary Prophylaxis of GOV II and IGV I

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075760
• Other study ID #: EUS-PP-GV
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 2020

Study information

• Verified date: October 2019
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: Carlos Robles-Medranda, M.D.
• Phone: +593-042109180
• Email: carlosoakm[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.

Description:

Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring >2 U of blood or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I.

The beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial.

The investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Above 18 years old

• Writeen informed consent provided.

• Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.

• Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)

• Patient preference for EUS-guided therapy.

Exclusion Criteria:

• Under 18 years old.

• Refuse to sign written informed consent.

• Pregnancy or nursing.

• Previous treatment of gastric varices.

• Non-cirrhotic portal hypertension

• Concurrent hepato-renal syndrome and/or multi-organ failure.

• Proven malignancy including hepatocellular carcinoma

• Platelet count less than 50,000/ml or International Normalized Rate (INR) >2.

• Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.

• Esophageal stricture.

• Uncontrolled coagulopathy.

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Gastric Varix
• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage

Intervention

Procedure:
• Coils + Cyanoacrylate Group + beta-blocker
EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I Patients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group.

Drug:
• beta blocker therapy
A beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.

Locations

Country	Name	City	State
Ecuador	Instituto Ecuatoriano de Enfermedades Digestivas	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (1)

Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding rate secondary to gastric varices	Number of patients with melena or hematemesis accompanied by Hemoglobin drop > 2g/dL	12 months
Primary	Mortality secondary to gastrointestinal bleeding	mortality rate	12 months
Secondary	Number of reinterventions	number of endoscopic or endoscopic ultrasound procedures requiered for the management of gastri varices	12 months