Primary Prophylaxis of Gastric Variceal Bleed

NCT02468180 — Not applicable, Unknown, 70 participants, West China Hospital

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Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration

Registry	NCT02468180
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	70 (Estimated)
Sponsor	West China Hospital (Other)
Conditions	Gastric Varices
Interventions	Balloon-occluded retrograde transvenous obliteration, Endoscopic cyanoacrylate injection, N-butyl-2-cyanoacrylate, Lauromacrogol (Procedure, drug)
Dates	start 2015-06-01, primary completion 2022-07-01 (estimated), completion 2022-07-01 (estimated), first posted 2015-06-10, last updated 2021-11-23
Locations	1 site in China

-Summary

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.

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+Arms and interventions

Arm	Type	Interventions	Description
BRTO	Active comparator	Procedure: Balloon-occluded retrograde transvenous obliteration; Drug: Lauromacrogol	Balloon-occluded retrograde transvenous obliteration
NBCA	Active comparator	Procedure: Endoscopic cyanoacrylate injection; Drug: N-butyl-2-cyanoacrylate	Endoscopic cyanoacrylate injection

Balloon-occluded retrograde transvenous obliteration (Procedure): Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injection (Procedure): Endoscopic cyanoacrylate injection
N-butyl-2-cyanoacrylate (Drug)
Lauromacrogol (Drug)

+Outcome measures

Primary outcomes

Bleeding rate from gastric varices [3 years]

Secondary outcomes

Eradication rate of gastric varices [3 years]
Number of participants with increase or decrease in the size of gastric varices [3 years]
Number of participants with appearance or worsening of new oesophageal varices [3 years]
Number of participants with appearance or worsening of portal hypertensive gastropathy [3 years]
Number of participants with appearance or worsening of ascites [3 years]
Number of participants with complication [3 years]
Average in-hospital stay [3 years]
Cost of treatment [3 years]
Mortality rate [3 years]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

1. Cirrhosis
2. Patients with high risk gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Acute bleed or past history of bleed from gastric varices
2. Previous treatment of gastric varices.
3. Non-cirrhotic portal hypertension
4. Contraindications to cyanoacrylate injection or BRTO
5. Portal cavernoma
6. Hepatorenal syndrome
7. Proven malignancy including hepatocellular carcinoma
8. End-stage renal disease under renal replacement therapy;
9. Cardiorespiratory failure
10. Pregnancy or patients not giving informed consent for endoscopic procedures

+Locations (1)

Facility	City	Country	Status
West China Hospital	Chengdu, Sichuan	China	Recruiting

My Notes

Public

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