Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00732212 |
Other study ID # |
CLIN-013-07F |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 18, 2009 |
Est. completion date |
January 7, 2016 |
Study information
Verified date |
April 2022 |
Source |
VA Office of Research and Development |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The main purposes of this study are to compare clinical outcomes of two groups of patients
with similar medical conditions (one with non-variceal upper gastrointestinal (UGI) lesions
such as ulcers and another group with varices or portal hypertensive lesions) who are treated
either with current standard visually guided endoscopic treatment according to stigmata of
hemorrhage or with endoscopic Doppler endoscopic ultrasound probe (DEP) monitoring of blood
flow in the lesion.
Description:
Background: For patients with severe upper gastrointestinal (UGI) hemorrhage, risk
stratification for rebleeding or endoscopic hemostasis has been based on visually defined
endoscopic stigmata of hemorrhage for more than 40 years. These are imperfect, because there
is significant interobserver variation and the investigators were previously unable to detect
underlying vessel blood flow, which is directly related to the risk of rebleeding. Doppler
ultrasound endoscopic probes (DEP) are relatively new in the US and can detect underlying
lesion blood flow. However, few patients with severe UGI hemorrhage have been studied with
endoscopic doppler ultrasound probe in the US and none in VA's. The Center for Ulcer Research
and Education (CURE)/VA GI Hemostasis Research Group will perform prospective randomized
studies at the West Los Angeles VA and University of California Los Angeles (UCLA) Ronald
Reagan Medical Centers to define the role of DEP in management of severe UGI hemorrhage.
Objectives: The specific aims (SA) of this research are: #1) In a randomized, blinded
prospective controlled (RCT) study of patients with severe UGI hemorrhage (from
varices/portal hypertensive lesions as one separate group vs. ulcers, & other benign
non-variceal sources as another group) to compare 30 day outcomes of patients in these 2
major disease groups, managed by current standards (according to endoscopic visualization &
stigmata of hemorrhage) with similar patients assessed, risk stratified, & treated with DEP
monitoring. #2). For patients randomized to the DEP group, to determine the initial
prevalence, type (arterial or venous), & location & course of blood flow underlying stigmata
for the different lesion groups. #3). For DEP patients with different lesion types, to
determine the rates of persistent blood flow after endoscopic hemostasis treatments & whether
blood flow after under stigmata can be eliminated by further endoscopic hemostasis with
different techniques. #4). To determine the proportion of patients whose risk stratification
(for rebleeding) &/or endoscopic treatment are changed by utilizing DEP for detection of
blood flow under stigmata of hemorrhage or lesions before as a guide for endoscopic treatment
& absence of flow after treatment as a treatment endpoint rather than visual guidelines
(stigmata) alone for endoscopic treatment. #5). To compare the outcomes for a large cohort of
historical controls previously treated for hemostasis of the two lesion types in the UGI
tract by the CURE/VA Hemostasis Research Group according to visual guidelines & stigmata
alone with patients in the RCT managed with DEP findings & stigmata, contrasting
demographics, hemostasis rates, rebleeding rates & other outcomes up to 30 days for major
diagnoses (ulcers and other non-variceal lesions vs varices & other lesions related to portal
hypertension). #6). For patients who are treated with surgery or angiography for continued
bleeding or rebleeding of UGI lesions, to correlate & compare their vessel depth & location
(relative to stigmata), type of vessel, & lumen patency at surgery or angiography vs. Doppler
endoscopic probe findings recorded previously. Research Plan and Methods: All studies will be
performed over 5 years. The investigators will utilize a large RCT (blinded), a very large
cohort study, & prospective observational studies to complete the specific aims of the study.
Statistical Analysis System (SAS) will be utilized for data management. For SA #1, about 240
new patients (150 with non-variceal lesions and 90 with variceal-portal hypertensive lesions)
admitted to West Los Angeles (WLA) VA or UCLA Hospitals with severe UGI hemorrhage will be
randomized in RCT of Doppler assisted management versus standard endoscopic/medical
diagnosis, risk stratification, & treatment. During urgent endoscopy, patients with clean
varices (as the source of bleeding) or other UGI lesions with stigmata of recent hemorrhage
(from the ulcers, Mallory Weiss tears, esophageal or gastric varices, and Dieulafoy's
lesions) will be randomized. Routine clinical outcomes will be assessed prospectively &
compared by major diagnostic groups (ulcers-non-variceal lesions or varices-portal
hypertensive lesions). For SA #5 (UGI cohort study), demographics, outcomes, & risk factors
will be compared for about 150 patients with non-variceal lesions & about 90 other
variceal-portal hypertensive lesion matched historical control patients (from CURE Hemostasis
Research Databases) treated previously only based upon stigmata vs. 75 new patients with
non-variceal UGI lesions or 50 variceal-portal hypertension lesions in this study treated
according to stigmata of hemorrhage & DEP as a guide to risk stratification & endoscopic
hemostasis. SA #2-4 & 6 will be prospectively performed according to the methods in the
proposal & all analysis will be performed with the collaboration of an experienced
biostatistician.
Potential Impact on Veterans and Non- VA Healthcare: These studies will increase our
knowledge about UGI bleeding, UGI lesion vasculature, blood flow, and effects of endoscopic
hemostasis. Also, DEP may improve risk stratification of Veteran patients, medical and
endoscopic management & outcomes of patients with severe UGI hemorrhage from different
etiologies. This is particularly relevant to patient care of Veterans with severe UGI
hemorrhage, since this is a common clinical condition which requires considerable health care
resources in every VA hospital. These results will also be generalizable to non-VA hospitals
and the US population who is hospitalized with severe UGI bleeding.