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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic ultrasound Placement of coil and glue | Other | Single arm study The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue Duration 1,3,06 months for observation of gastric varices bleeding... |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound placement of Coil and glue | Device | The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue |
|
| Measure | Description | Time Frame |
|---|---|---|
| The outcome will measure number of patient had achieved complete obliteration of varices | Repeat Endoscopic ultrasound findings of residual flow | 6 months for observation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient needed re intervention | Repeat coil application on follow-up | 6 months for observation |
| Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days) |
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Inclusion criteria: -
Each patient must meet all the following criteria to be enrolled in this study:
Exclusion criteria: -
The exclusion criteria for these volunteers will be:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jahangeer Dr Basha, MD DM | Contact | 04023378888 | 231 | drjahangeer09@gmail.com |
| Sandeep Dr Nath, MD | Contact | 04023378888 | 121 | sandip.nath@ymail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohan Dr Ramchandani, MD DM | Asian Institute of Gastroenterology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian institute of Gastroenterology | Recruiting | Hyderabad | Telangana | 500082 | India |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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These are the definite data which will be statistically analyzed
| 90 days |