Esophageal VaricesPhase 4LOVARBNCT03624517
Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices
A Phase 4 study testing Octreotide in people with Esophageal Varices and Liver Cirrhoses, run by Medical University of South Carolina at 8 sites in United States.
Trial summary
This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices
- What is being tested?
- Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Sep 2018to 1 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females who are 18 years of age or older.
- Evidence or suspicion of upper gastrointestinal bleed (GIB)
- Patient with known or suspected cirrhosis
- Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation
- Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so
Who cannot join
- Known upper gastrointestinal malignancy
- Bleeding from gastric varices, with or without esophageal varices
- Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
- Variceal bleeding in the last 90 days
- History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
- Pregnant females
Show all 10Show fewer
- Incarcerated individuals
- Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
- Non-cirrhotic portal hypertension causing esophageal varices
- Known or suspected allergy to octreotide
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The University of Texas at Austin
Austin, Texas, 78712
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois at Chicago
Chicago, Illinois, 60607
The Ohio state University
Columbus, Ohio, 43210
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Brooke Army Medical Center
Houston, Texas, 78234
University of Florida Health
Jacksonville, Florida, 32209
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study
This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.
Read the detailed description
In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.
Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.
This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.
- Conditions
- Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices, Upper Gastrointestinal Bleeding
- Being tested
- Octreotide
- Medical subject headings
- Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
| Study group | Role | What they receive |
|---|---|---|
| 24-hour octreotide infusion | Experimental | Patients will receive octreotide infusion over 24 hours Receives: Drug: Octreotide |
| 72-hour octreotide infusion | Active comparator | Patients will receive octreotide infusion over 72 hours Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
Rebleeding within 72-hours will be defined as any of the following:
- A drop in hemoglobin by more than 20 percentage points from baseline
- Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena
- Transfusion of >2 unites packed red blood cells after esophageal band ligation
- Recurrence of hematemesis or ongoing melena
- Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding
Measured: 72 hours
Secondary outcomes (2)
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed
Rebleeding after 72-hours will be defined as:
- Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability)
- Drop in hemoglobin by more than 20 percentage points OR the need for >2 units packed red blood cells
- Need for TIPS or surgery to control suspected bleeding
Measured: 7 days and 30 days
Survival at 7 Days and 30 Days After Control of Initial Bleed
Survival at 7 days and 30 days.
Measured: 7 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start19 Sep 2018
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Why it stopped: Recruitment was severely affected due to COVID, so study was stopped prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of Texas Southwestern Medical Center, University of Florida Health
- Responsible party
- Sponsor
- Investigators
- Don Rockey, M.D, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624517
- Sponsor's protocol ID
- Pro00027015
- Acronym
- LOVARB
- Status last verified
- Nov 2025
- First submitted
- 31 Jul 2018
- Last updated
- 20 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allam J, De Melo S, Feagins LA, Agrawal D, Malespin M, Shuja A, Lara LF, Rockey DC. Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial. Am J Med Sci. 2025 Jan;369(1):71-76. doi: 10.1016/j.amjms.2024.08.027. Epub 2024 Sep 4.
PubMed 39241828
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03624517
- Acronym / sponsor ID
- LOVARB / Pro00027015
- Conditions
- Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices, Upper Gastrointestinal Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was severely affected due to COVID, so study was stopped prematurely.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Ohio State University, University of Texas Southwestern Medical Center, University of Florida Health
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 20 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.
Detailed description
In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.
Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.
This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24-hour octreotide infusion | Experimental | Drug: OctreotidePatients will receive octreotide infusion over 24 hours |
| 72-hour octreotide infusion | Active comparator | Drug: OctreotidePatients will receive octreotide infusion over 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult males and females who are 18 years of age or older.
- Evidence or suspicion of upper gastrointestinal bleed (GIB)
- Patient with known or suspected cirrhosis
- Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation
- Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so
Key exclusion criteria (10 listed)
- Known upper gastrointestinal malignancy
- Bleeding from gastric varices, with or without esophageal varices
- Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
- Variceal bleeding in the last 90 days
- History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctreotideOctreotide infusion for 24-hours in patients with bleeding esophageal varices. | Drug | 24-hour octreotide infusion, 72-hour octreotide infusion |
Primary outcome
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
Time frame: 72 hours
Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of >2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding
2 secondary outcomes
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed
Time frame: 7 days and 30 days
Survival at 7 Days and 30 Days After Control of Initial Bleed
Time frame: 7 days and 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39241828Allam J, De Melo S, Feagins LA, Agrawal D, Malespin M, Shuja A, Lara LF, Rockey DC. Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial. Am J Med Sci. 2025 Jan;369(1):71-76. doi: 10.1016/j.amjms.2024.08.027. Epub 2024 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Rockey, M.D principal investigator
Medical University of South Carolina
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Octreotide in people with Esophageal Varices and Liver Cirrhoses, run by Medical University of South Carolina at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.