Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05629845 |
| Other study ID # |
2022.410 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2022 |
| Est. completion date |
May 1, 2026 |
Study information
| Verified date |
December 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
Raymond S Tang, MD |
| Phone |
(852) 26370428 |
| Email |
raymondtang[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rebleeding rate is high in hepatocellular carcinoma (HCC) patients with variceal bleeding
despite conventional endoscopic therapies for esophageal and gastric varices (EV, GV).
Secondary prevention of variceal rebleeding was reported to improve outcomes of HCC patients,
but the optimal endoscopic approach is not well defined. In this difficult-to-manage
population, variceal rebleeding rates remain substantial after conventional endoscopic
therapies. n recent studies by others and our group on direct EUS-guided therapy for varices
in cirrhotic patients, high technical success (90 - 100%), low post-treatment rebleeding rate
(3 - 11%) and low adverse event rate (~3%) have been reported for GV treatment by
cyanoacrylate glue injection, coiling or a combination of both, and for cyanoacrylate glue
injection or coiling of EV refractory to variceal band ligation (VBL). This study aims to
compare rebleeding rates after secondary prevention by EUS-guided therapy or conventional
endoscopic therapy in HCC patients with recent variceal bleeding.
Description:
Chronic liver diseases and cirrhosis are common health problems in the Asia-Pacific region.
In 2015, 54.3% of global deaths due to cirrhosis occurred in the Asia-Pacific region. Acute
variceal bleeding is a life-threatening complication of cirrhosis that occurs at a rate of 10
- 15% per year, with a 6-week mortality rate up to 25%. In patients with successful acute
bleeding control by endoscopic therapy and vasoactive agents, rebleeding is common in those
without subsequent secondary prevention by non-selective beta blocker and/or endoscopic
therapy (e.g. variceal band ligation (VBL) for esophageal varices (EV) and glue injection for
gastric varices (GV)).
Apart from variceal bleeding, hepatocellular carcinoma (HCC) (liver cancer) is another
important complication of cirrhosis. HCC patients with prior variceal bleeding are at high
risk of rebleeding due to significant portal hypertension and frequent presence of portal
vein thrombosis (PVT). In this difficult-to-manage population, variceal rebleeding rates
remain substantial after conventional endoscopic therapies. In a large multicenter study
comparing clinical outcomes after EV bleeding in patients with or without HCC, lack of
secondary prevention for rebleeding was found to be frequent in HCC patients and was
associated with a higher rate of rebleeding and mortality. In HCC patients with EV bleeding,
secondary prevention failure by conventional endoscopic therapy was significantly higher (50%
vs 31%, P = 0.001) when compared with patients without HCC. However, the optimal endoscopic
approach for secondary prevention in HCC patients has not been well defined. Whether commonly
used endoscopic techniques such as VBL for EV and cyanoacrylate glue injection for GV being
performed at intervals of 3 - 4 weeks for secondary prevention can achieve durable variceal
control in HCC patients remains unclear.
Direct endoscopic ultrasound (EUS)-guided variceal interventions by cyanoacrylate glue
injection, coiling, or a combination of both using a therapeutic curvilinear echoendoscope is
a novel endoscopic technique that have attracted clinical attention due to its high efficacy
in variceal control. In recent studies by others and our group on direct EUS-guided therapy
for varices in cirrhotic patients, high technical success (90 - 100%), low post-treatment
rebleeding rate (3 - 11%) and low adverse event rate (~3%) have been reported for GV
treatment by cyanoacrylate glue injection, coiling or a combination of both, and for
cyanoacrylate glue injection or coiling of EV refractory to VBL.
In a retrospective study published by our group in 2020, we compared outcomes in 27 HCC
patients with variceal bleeding who underwent secondary prevention by EUS-guided glue
injection every 12 weeks and 33 HCC patients without secondary prevention after control of
acute variceal bleeding. The technical success of EUS-guided therapy was 100%. The overall
procedure-related adverse event rate was low (3.7%) and no radiographic evidence of
glue-lipiodol embolization was observed. The EUS-guided therapy group was found to have a
significantly lower 90-day death-adjusted cumulative incidence of rebleeding and a
significantly higher variceal bleeding-free survival at 3 and 6 months. As such, it would be
clinically important to conduct a prospective randomized controlled study to confirm the
benefits of EUS-guided therapy for secondary prevention in HCC patients.
