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| Name | Class |
|---|---|
| Yale University | OTHER |
| VA Connecticut Healthcare System | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligation: 1-week interval | Active Comparator | Endoscopic variceal ligation performed at 1-week intervals |
|
| Ligation 2-week interval | Active Comparator | Endoscopic variceal ligation performed at 2-week intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Variceal Ligation | Device | Ligation of esophageal varices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Eradication of Esophageal Varices | At 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loren Laine, M.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L.A. County + U.S.C. Medical Center | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ligation: 1-week Interval | Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices |
| FG001 | Ligation 2-week Interval | Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ligation: 1-week Interval | Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices |
| BG001 | Ligation 2-week Interval |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Eradication of Esophageal Varices | Posted | Count of Participants | Participants | At 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ligation: 1-week Interval | Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | Per the study design, this predefined outcome that we collected and reported was the serious adverse event of hospitalization (not specific etiologies). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal | Gastrointestinal disorders | Systematic Assessment | This predefined outcome included any of the esophageal symptoms of dysphagia, odynophagia, and/or chest pain (a composite endpoint). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Loren Laine | Yale School of Medicine | 203-937-3462 | loren.laine@yale.edu |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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Endoscopic variceal ligation performed at 2-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Participants |
|
|
| 16 |
| 45 |
| 4 |
| 45 |
| EG001 | Ligation 2-week Interval | Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices | 15 | 45 | 1 | 45 |
|
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |