EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I (NCT04075760) | Clinical Trial Compass
UnknownNot Applicable
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Ecuador26 participantsStarted 2019-08-01
Plain-language summary
The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Above 18 years old
* Writeen informed consent provided.
* Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.
* Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)
* Patient preference for EUS-guided therapy.
Exclusion Criteria:
* Under 18 years old.
* Refuse to sign written informed consent.
* Pregnancy or nursing.
* Previous treatment of gastric varices.
* Non-cirrhotic portal hypertension
* Concurrent hepato-renal syndrome and/or multi-organ failure.
* Proven malignancy including hepatocellular carcinoma
* Platelet count less than 50,000/ml or International Normalized Rate (INR) \>2.
* Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
* Esophageal stricture.
* Uncontrolled coagulopathy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bleeding rate secondary to gastric varices
Timeframe: 12 months
2
Mortality secondary to gastrointestinal bleeding
Timeframe: 12 months
Trial details
NCT IDNCT04075760
SponsorInstituto Ecuatoriano de Enfermedades Digestivas