Variceal BleedingPhase 4NCT01291277
Time Interval for Endoscopic Variceal Ligation
A Phase 4 study testing Endoscopic Variceal Ligation in people with Variceal Bleeding, run by University of Southern California at 1 site in United States.
Trial summary
Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Variceal Bleeding
- What is being tested?
- Endoscopic Variceal Ligation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2015
- 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
- Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation.
- Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices.
Who cannot join
- Persistent bleeding despite endoscopic and medical therapy
- Platelet count < 40,000
Trial locations and contacts
1 site in 1 country.
United States1 site
L.A. County + U.S.C. Medical Center
Los Angeles, California, 90033
About this study
Official title: Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices
Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.
- Conditions
- Variceal Bleeding
- Being tested
- Endoscopic Variceal Ligation
- Keywords
- gastrointestinal hemorrhage, esophageal varices, gastrointestinal endoscopy, ligation
- Medical subject headings
- Gastrointestinal Hemorrhage, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Variceal LigationDevice
Also called variceal banding
Ligation of esophageal varices
| Study group | Role | What they receive |
|---|---|---|
| Ligation: 1-week interval | Active comparator | Endoscopic variceal ligation performed at 1-week intervals Receives: Device: Endoscopic Variceal Ligation |
| Ligation 2-week interval | Active comparator | Endoscopic variceal ligation performed at 2-week intervals Receives: Device: Endoscopic Variceal Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Eradication of Esophageal Varices
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startAug 2008
- Primary completionSep 2015
- Study completionDec 2015
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.
- Other trials for Variceal BleedingStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, VA Connecticut Healthcare System
- Responsible party
- Principal investigator, Loren Laine, University of Southern California
- Investigators
- Loren Laine, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291277
- Sponsor's protocol ID
- HS-08-00172
- Status last verified
- Dec 2016
- First submitted
- 4 Feb 2011
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices
- ClinicalTrials.gov ID
- NCT01291277
- Acronym / sponsor ID
- HS-08-00172
- Conditions
- Variceal Bleeding
- Keywords
- gastrointestinal hemorrhage, esophageal varices, gastrointestinal endoscopy, ligation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Yale University, VA Connecticut Healthcare System
- Study start
- Aug 2008
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Posted 26 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligation: 1-week interval | Active comparator | Device: Endoscopic Variceal LigationEndoscopic variceal ligation performed at 1-week intervals |
| Ligation 2-week interval | Active comparator | Device: Endoscopic Variceal LigationEndoscopic variceal ligation performed at 2-week intervals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation.
- Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices.
Key exclusion criteria (2 listed)
- Persistent bleeding despite endoscopic and medical therapy
- Platelet count < 40,000
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 |
|---|---|---|
| Endoscopic Variceal LigationAlso: variceal bandingLigation of esophageal varices | Device | Ligation 2-week interval, Ligation: 1-week interval |
Primary outcome
Proportion of Patients With Eradication of Esophageal Varices
Time frame: At 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Loren Laine, M.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endoscopic Variceal Ligation in people with Variceal Bleeding, run by University of Southern California at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 Dec 2016). 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?
Proportion of Patients With Eradication of Esophageal Varices (time frame: At 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2017.