Octreotide Infusion Duration for Esophageal Varices
(LOVARB Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Medical University of South Carolina
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial compares the safety and effectiveness of shorter versus longer octreotide infusion in cirrhotic patients with bleeding esophageal varices. Octreotide helps lower blood pressure in liver vessels, reducing bleeding risks. The study aims to see if a shorter treatment duration is just as safe and effective, potentially lowering hospital costs. Octreotide is a synthetic long-acting somatostatin analogue used to control acute esophageal variceal bleeding by reducing variceal blood flow and pressure.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does not mention any specific requirements to stay on or stop existing medications.
What data supports the idea that Octreotide Infusion Duration for Esophageal Varices is an effective drug?
The available research shows that octreotide is effective in controlling bleeding from esophageal varices. In one study, octreotide controlled bleeding in 88% of patients within 6 hours, compared to 54% for another drug, vasopressin. Another study found that octreotide and a procedure called sclerotherapy were equally effective, but octreotide had fewer side effects. Overall, octreotide is shown to be effective and has fewer side effects compared to some alternatives.
12345What safety data exists for octreotide in treating esophageal varices?
Octreotide has been shown to be effective in controlling acute esophageal variceal bleeding with fewer side effects compared to vasopressin. Common side effects include headache, chest pain, and abdominal pain, which are less frequent with octreotide than with vasopressin. It is generally well-tolerated and has been used safely in patients without serious cardiovascular disease. However, the optimal dosage, duration, and route of administration are still under investigation, and more controlled trials are needed to fully establish its safety profile.
12456Is the drug Octreotide a promising treatment for esophageal varices?
Yes, Octreotide is a promising treatment for esophageal varices. It is effective in controlling bleeding, has fewer side effects compared to other treatments like vasopressin, and is easy to administer. It also helps reduce pressure in the veins, which can prevent further bleeding.
12345Eligibility Criteria
This trial is for adults with cirrhosis who have had an upper gastrointestinal bleed due to bleeding esophageal varices and need band ligation. They must be able to consent or have a representative do so. Excluded are those with GI cancer, recent variceal bleeding, prior shunt surgery, pregnancy, incarceration, severe recent illness, non-cirrhotic portal hypertension or octreotide allergy.Inclusion Criteria
I might have bleeding in my upper digestive tract.
I can give my consent for the study or have someone legally authorized to do so on my behalf.
I am 18 years old or older.
+2 more
Exclusion Criteria
I have bleeding from stomach veins.
I have had bleeding from enlarged veins in my esophagus or stomach in the last 3 months.
People who are in prison.
+7 more
Participant Groups
The study tests the effectiveness of two durations of octreotide infusion—24 hours versus 72 hours—in preventing rebleeding from esophageal varices after endoscopic banding in patients with liver cirrhosis.
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-hour octreotide infusionExperimental Treatment1 Intervention
Patients will receive octreotide infusion over 24 hours
Group II: 72-hour octreotide infusionActive Control1 Intervention
Patients will receive octreotide infusion over 72 hours
Octreotide is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Sandostatin for:
- Acromegaly
- Severe diarrhea for carcinoid syndrome
🇪🇺 Approved in European Union as Sandostatin for:
- Acromegaly
- Symptoms associated with carcinoid tumors and vasoactive intestinal peptide secreting tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Tech University Health Sciences CenterEl Paso, TX
Medical University of South CarolinaCharleston, SC
The Ohio state UniversityColumbus, OH
University of Florida HealthJacksonville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
University of Texas Southwestern Medical CenterCollaborator
Ohio State UniversityCollaborator
University of Florida HealthCollaborator
References
A randomized controlled trial comparing octreotide and vasopressin in the control of acute esophageal variceal bleeding. [2019]This randomized controlled trial was conducted to compare the efficacy of intravenous infusion of octreotide (a synthetic long-acting somatostatin analogue) with vasopressin in 48 cirrhotic patients with endoscopically proven bleeding esophageal varices. Twenty-four patients received a continuous infusion of octreotide 25 micrograms/h for 24 h after an initial bolus of 100 micrograms and another 24 patients received a continuous infusion of vasopressin 0.4 U/min for 24 h. Bleeding was initially controlled after 6 h of drug infusion in 88% (21/24) and 54% (13/24) of the patients treated with octreotide and vasopressin respectively (p = 0.03). Complete control of bleeding after 24 h of drug infusion was achieved in 15 (63%) patients receiving octreotide and in 11 (46%) patients receiving vasopressin (p > 0.05). Side effects during drug infusion such as headache, chest pain and abdominal pain were significantly lower in the octreotide group (3/24) than in the vasopressin group (11/24). Serum gastrin and insulin levels fell significantly following octreotide infusion, but plasma glucose levels remained unchanged. Mortality related to bleeding esophageal varices was no different between the two groups. This report showed that octreotide infusion was more effective and had fewer side effects than vasopressin in initial controlling of acute esophageal variceal bleeding until an elective endoscopic sclerotherapy could be performed.
Use of octreotide in the acute management of bleeding esophageal varices. [2019]Acute hemorrhage from esophageal varices is a medical emergency; despite early diagnosis and treatment the associated hospital mortality remains high. The clinical research summarized in this paper shows that octreotide has a beneficial effect on portal hemodynamics in cirrhotic patients. In randomized controlled trials octreotide has been effective in halting initial hemorrhage and in preventing reoccurrence of bleeding. Somatostatin and octreotide appear to be equivalent in terms of therapeutic efficacy but octreotide is the less expensive option. For suspected variceal bleeding an octreotide infusion should be initiated immediately. To prevent further bleeding the drug should be continued for two to five days after endoscopic variceal ligation.
Octreotide infusion or emergency sclerotherapy for variceal haemorrhage. [2019]To compare octreotide with injection sclerotherapy in the treatment of acute variceal haemorrhage, patients admitted with gastrointestinal bleeding and oesophageal varices confirmed by endoscopy were randomised to receive either emergency sclerotherapy with 3% sodium tetradecyl sulphate or octreotide (50 micrograms intravenous bolus plus 50 micrograms per h intravenous infusion for 48 h). At the end of the study period (48 h), the octreotide group also had sclerotherapy to obliterate the varices. 100 patients were recruited. Demographic features including the aetiology of portal hypertension and the Child-Pugh's grading of the two groups were similar. Bleeding was initially controlled in 90% of patients by emergency sclerotherapy and in 84% by octreotide infusion (95% confidence interval 0-19.5, p = 0.55). There were no significant differences between the two groups in early (within 48 h of randomisation) rebleeding (16% vs 14%), blood transfusion (3 units vs 3.5), hospital stay (5 days vs 6 days), or hospital mortality (27% vs 20%). No notable side-effects were associated with octreotide. We conclude that octreotide infusion and emergency sclerotherapy are equally effective in controlling variceal haemorrhage.
Effect of early octreotide administration on the development of esophageal varices in cirrhotic rats. [2020]This study was conducted to investigate the effect of chronic octreotide administration on the development of esophageal varices in rats being at the early stages of carbon tetrachloride-induced cirrhosis. For the development of liver cirrhosis and esophageal varices 96 rats underwent ligation of left adrenal vein followed by phenobarbital and carbon tetrachloride administration. After 2 weeks of carbon tetrachloride administration, rats were randomly separated into three groups. Chronic octreotide administration started in group A, normal saline in group B, while 32 rats consisted control group. Haemodynamic studies and morphometric analysis of the lower esophagus were performed 2 weeks after complete induction of cirrhosis. Total submucosal vessel area, mean cross-sectional area of submucosal vessels, percentage of submucosa occupied by vessels, the area of the most dilated submucosal vessel as well as the number of submucosal vessels were studied. Octreotide administration induced a significant ( [Formula: see text] ) decrease of portal vein pressure. Morphometric analysis revealed a significant reduction ( [Formula: see text] ) in octreotide-treated rats of both "total submucosal vessel area" and area of "the most dilated submucosal vessel". Chronic octreotide administration partially prevented rats from the development of esophageal varices. Octreotide-treated rats were found to have a less pronounced dilatation of submucosal veins compared to placebo-treated group rats. We believe that this effect was mainly due to the decrease of portal vein pressure induced by chronic octreotide administration.
A study of octreotide in oesophageal varices. [2018]A comparison of octreotide infusion (25 micrograms/h) and placebo in 16 stable cirrhotic patients revealed a 30% reduction in transhepatic venous gradient between 0 and 60 min in the octreotide group without an effect on systemic haemodynamics. In a separate trial, 40 patients with active variceal bleeding were randomized to octreotide infusion (25 micrograms/h for 48 h) or oesophageal tamponade. The 2 treatments gave comparable control of variceal bleeding. Tolerance of treatment was significantly better in the octreotide group. In summary, octreotide infusion is simple to administer, has few side effects, and may be of use in the immediate control of oesophageal bleeding.
Octreotide or vasopressin for bleeding esophageal varices. [2019]Acute bleeding due to esophageal varices continues to be a life-threatening complication of liver disease. Despite the availability of improved therapy, mortality continues to be high. Octreotide has been shown to be at least as effective as vasopressin in the treatment of bleeding varices, with fewer and less severe systemic adverse effects. In addition, octreotide has also been consistently associated with a decreased need for transfusions. Octreotide has been used safely in patients without serious cardiovascular disease when administered as a continuous intravenous infusion of 25 micrograms/h for 24 hours with or without an initial 100-micrograms bolus dose. Since these trials have used small numbers of patients, the ability to detect small but clinically important differences has been limited. Additional controlled trials comparing octreotide with the combination of vasopressin and nitroglycerin are needed to more clearly determine the efficacy and cost-effectiveness of therapy. Furthermore, the optimal dosage, duration, and route of administration of octreotide in the treatment of bleeding esophageal varices has yet to be determined.