EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
EUS
Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2024
CompletedApril 17, 2024
March 1, 2024
1.7 years
December 21, 2023
April 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The outcome will measure number of patient had achieved complete obliteration of varices
Repeat Endoscopic ultrasound findings of residual flow
6 months for observation
Secondary Outcomes (2)
Number of patient needed re intervention
6 months for observation
Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)
90 days
Study Arms (1)
Endoscopic ultrasound Placement of coil and glue
OTHERSingle 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...
Interventions
The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue
Eligibility Criteria
You may qualify if:
- Each patient must meet all the following criteria to be enrolled in this study:
- Gastric fundal varices larger than 2.0 cm in total diameter
- High risk GV (GOV 2/IGV 1)
- Primary prophylaxis
- Patients with known fundal varices
- Ability to give a signed informed consent
You may not qualify if:
- Patients with a history of TIPS or any other portosystemic shunt procedure
- Oesophageal stricture
- Patient not fit for general anaesthesia
- Secondary prophylaxis
- Pediatric Patients (\<18 years)
- Pregnant or lactating mother
- Not willing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asian institute of Gastroenterology
Hyderabad, Telangana, 500082, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohan Dr Ramchandani, MD DM
Asian Institute of Gastroenterology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
December 21, 2023
First Posted
April 17, 2024
Study Start
August 1, 2022
Primary Completion
March 30, 2024
Study Completion
August 10, 2024
Last Updated
April 17, 2024
Record last verified: 2024-03