Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06370169 |
| Other study ID # |
ROSC 1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
August 10, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Asian Institute of Gastroenterology, India |
| Contact |
Jahangeer Dr Basha, MD DM |
| Phone |
04023378888 |
| Email |
drjahangeer09[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The standard treatment of bleeding gastric varices is obliteration with placement of coil and
glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for
high-risk gastric varices. All procedures will be performed with patient under deep sedation
or general anaesthesia under the supervision of an anaesthesiologist.
Description:
In this study Principal investigator recruiting patients with high-risk gastric varices for
primary prophylaxis. Gastric varices are dilated submucosal veins in the lining of the
stomach, found in patients with portal hypertension or elevated pressure in the portal venous
system. The standard treatment of bleeding gastric varices is obliteration with placement of
coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis
for high-risk gastric varices. All procedures will be performed with patient under deep
sedation or general anaesthesia under the supervision of an anaesthesiologist. After the
procedure patients will be discharged to home unless there is any indication for admission,
such as significant abdominal pain, bleeding or chest pain. For enrolment into the study,
patient has to sign an informed consent form which is provided at the end. First, we will do
baseline evaluation of the patient which includes detailed clinical examination, routine
laboratory tests, Upper GI Endoscopy, triphasic CT abdomen. The duration of study is 6
months. Only the routine tests necessary for the management of disease will be charged.
