A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Blee… (NCT01267669) | Clinical Trial Compass
CompletedNot Applicable
A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
India61 participantsStarted 2005-11
Plain-language summary
Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.
Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.
Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.
Who can participate
Age range
12 Years – 75 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:
* Clinical diagnosis of portal hypertension
* Having hematemesis and/or melena within 24 hour prior to admission
* Source of bleeding should be esophageal varices
Exclusion Criteria:
* Non-cirrhotic cause of portal hypertension
* Age \<12 or \>75 years
* Hepatic encephalopathy grade 3 or 4
* Renal failure with serum creatinine \>2 mg/dL
* Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
* Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
* Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
* Patients with history of surgery for portal hypertension or TIPS
* Concomitant severe cardio-pulmonary disease
* Concomitant malignancy
* HVPG not possible within 24 hrs of presentation
* Patients refusing to participate in the study.
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.