Gastric Variceal Bleeding Clinical Trial
Official title:
A Randomized Tril of Endoscopic Cyanoacrylate Obliteration vs. Nadolol
Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate.
Gastric varies (GV) rarely rupture. However should it occur, the outcome would be worse than
rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding
rate, a requirement for a larger amount of blood transfusion and a higher mortality. Up to
date, the treatment of GV bleeding (GVB) is still sub-optimal in contrast to the treatment
of EV bleeding. The management of GV has been focused on treatment of acute GVB. Various
specific methods are used to control GVB and prevent rebleeding; however they were far from
ideal. It is because GV are usually larger vessels formed in deeper submucosa and connect to
the spontaneous gastrorenal shunt which creates a fast blood flow. Therefore, voluminous
blood in the larger diameter GV leads to exsanguine bleeding when ruptured. A variety of
endoscopic methods, which include injection of sclerosants, tissue adhesive (cyanoacrylate),
thrombin and ligation with rubber bands, detachable nylon loop and steel snares, are applied
to control acute GV bleeding with variable successful rates (50~100%) and rebleeding rates
(20~90%). The successful rate of endoscopic cyanoacrylate injection to arrest active GVB is
more consistent around 90~100% and rebleeding rate is around 30~40%. The recent
International Consensus Meeting endorsed that endoscopic cyanoacrylate injection is the
first line treatment for acute GVB. The embolic complications, either septic & aseptic, are
not uncommon. Expertise is also required to reduce the embolic complications and
instrumental injuries. Therefore, the efficacy of specific treatment for GVB is sub-optimal,
consecutive innovation of new methods are required to improve the prognosis of GVB.
Non-selective beta-blocker is effective to reduce rebleeding from esophageal varices.
However, its effect on gastric variceal hemorrhage has never been proven.
This is an important issues prompted by current portal hypertension experts. We have much
experience in the treatment of gastric variceal bleeding and published fruitful results in
high ranking journal. Therefore, we design a randomized trial to compare the effect of
endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the
secondary prevention of acute gastric variceal bleeding.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00735358 -
Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
|
Phase 4 | |
| Enrolling by invitation |
NCT05302661 -
Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis
|
N/A |