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Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices

Fudan University logo

Fudan University

Status

Completed

Conditions

Portal Hypertension
Gastric Varices

Treatments

Drug: Lauromacrogol
Drug: Lipiodol

Study type

Interventional

Funder types

Other

Identifiers

NCT01923064
chen2013

Details and patient eligibility

About

The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Full description

Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Enrollment

96 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.
  • The age of the patients range from 18 to 80 years old.

Exclusion criteria

  • Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.
  • Patients who have abnormal portosystemic shunt according to the imaging results.
  • Patients who have no previous upper gastrointestinal bleeding history.
  • Patients who have multiple endoscopic treatments for esophagogastric varices before.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

NBCA-lipiodol
Active Comparator group
Description:
Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices
Treatment:
Drug: Lipiodol
NBCA-lauromacrogol
Experimental group
Description:
Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices
Treatment:
Drug: Lauromacrogol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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