Variceal Bleeding
Conditions
Keywords
gastrointestinal hemorrhage, esophageal varices, gastrointestinal endoscopy, ligation
Brief 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 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.
Interventions
Ligation of esophageal varices
Sponsors
Yale University
VA Connecticut Healthcare System
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Persistent bleeding despite endoscopic and medical therapy * Platelet count \< 40,000
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients With Eradication of Esophageal Varices | At 4 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ligation: 1-week Interval Endoscopic variceal ligation performed at 1-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices | 45 |
| Ligation 2-week Interval Endoscopic variceal ligation performed at 2-week intervals
Endoscopic Variceal Ligation: Ligation of esophageal varices | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Ligation: 1-week Interval | Ligation 2-week Interval | Total |
|---|---|---|---|
| Age, Continuous | 53 years | 54 years | 54 years |
| Gender Female | 14 Participants | 7 Participants | 21 Participants |
| Gender Male | 31 Participants | 38 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 45 | 1 / 45 |
| serious Total, serious adverse events | 16 / 45 | 15 / 45 |
Outcome results
Primary
Proportion of Patients With Eradication of Esophageal Varices
Time frame: At 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ligation: 1-week Interval | Proportion of Patients With Eradication of Esophageal Varices | 37 Participants |
| Ligation 2-week Interval | Proportion of Patients With Eradication of Esophageal Varices | 23 Participants |