Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-14 @ 5:51 AM
Study NCT ID:
NCT04692805
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2020-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
Sponsor:
Tongji Hospital
Organization:
Study Overview
Official Title:
EUS-guided Partial Splenic Embolization in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.
Detailed Description:
Partial splenic embolization (PSE) was developed in the purpose of managing two common complications of portal hypertension including variceal bleeding and hypersplenism. The procedure is normally performed by clinicians engaged in interventional radiology via a transcatheter embolization method as the successful embolization of the selected splenic arteries results in devascularization of a focal lesion followed by splenic infarction and subsequently reducing the splenic contribution to the portal blood flow. Our previous case study suggests implanting coil in a branch of splenic artery under the endoscopic ultrasound (EUS) -guidance followed by the glue injection was an alternative PSE procedure to control hypersplenism. Recent advance has also heightened the therapeutic aspect of EUS in managing varices. We have established the novel approach to manage varices and hypersplenism at the same time by combining EUS-guided PSE and EUS-guided treatment of varices. This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: