Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05500625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-16
First Post:
2022-07-29
Brief Title:
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
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:
Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices The risk of bleeding from gastric varices is relatively low However the bleeding is usually significant and severe
Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding
Although this technique has been shown to be effective it is associated with many severe adverse events including systemic embolization fever chest pain and even death The rate of hemostasis has been reported to be as high as 91-100 but the rebleeding rate from gastric varices still present
Endoscopic ultrasound EUS guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling It offers the advantage of directly visualizing the varices and delivering targeted therapy
A standard endoscopic examination only allows the evaluation of superficial varices The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels which are directly involved in variceal development EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt
Balloon-occluded retrograde transvenous obliterationBRTO has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate
Despite all these promising results there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices Further prospective comparative studies are needed
Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding
Although this technique has been shown to be effective it is associated with many severe adverse events including systemic embolization fever chest pain and even death The rate of hemostasis has been reported to be as high as 91-100 but the rebleeding rate from gastric varices still present
Endoscopic ultrasound EUS guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling It offers the advantage of directly visualizing the varices and delivering targeted therapy
A standard endoscopic examination only allows the evaluation of superficial varices The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels which are directly involved in variceal development EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt
Balloon-occluded retrograde transvenous obliterationBRTO has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate
Despite all these promising results there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices Further prospective comparative studies are needed
Detailed Description:
None
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?:
None