Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2009
End Date:January 2016

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Doppler Ultrasound Probe for Blood Flow Detection in Severe UGI Bleed

The main purposes of this study are to compare clinical outcomes of two groups of patients
with similar medical conditions (one with non-variceal 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.

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 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 Doppler ultrasound probe (DUP) 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 2 major
disease groups - Non-variceal & Variceal-Portal hypertension lesions 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
DUP 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. 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 the
investigators' 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.

Inclusion Criteria:

- Patients must have evidence of severe UGI bleeding by laboratory tests (Hgb less than
or equal to 9 gms; with RBC transfusions; or documented decrease in Hgb of greater
than or equal to 2 gms relative to baseline) and by clinical parameters (melena;
hematemesis or hematochezia; nasogastric tube (NG) evidence of UGI bleeding- fresh
blood, clots, or old blood).

- The following non-variceal UGI lesions will be included if stigmata of hemorrhage are
found on emergency endoscopy (active arterial bleeding, oozing, non-bleeding visible
vessel (NBVV), adherent clot, or flat spot or a combination of these) for peptic
ulcers (gastric, duodenal, esophageal, or anastomatic), Mallory-Weiss (MW) tears
without portal hypertension (PHTN), or Dieulafoy's lesions.

- For other types of severe UGI bleeding related to PHTN, the investigators will also
include patients with esophageal or gastric varices (with or without stigmata, if no
other UGI lesion is the source of the bleed); post-rubber band ligation (RBL) ulcers,
and MW tears associated with PHTN and having some stigmata of recent hemorrhage.

- Life expectancy of at least 60 days based on lack of very severe or terminal
comorbidity, as judged by the generalists or specialists caring for the patient.

- Written informed consent by patient or surrogate.

Exclusion Criteria:

- Patients who are uncooperative, unable to give written informed consent, who cannot
return for 30 day follow-up, or refuse informed consent.

- Patients with UGI known malignancies or malignant appearing ulcers; diffuse bleeding
from mucosal lesions or esophagitis; infectious UGI lesions; or other bleeding
lesions (polyps, post-endoscopic mucosal resection (EMR), or post-sphincterotomy).

- End-stage, very severe, recurrent or ongoing co-morbid illness, e.g. severe liver,
renal, cardiac, respiratory failure; peritonitis; or sepsis that preclude emergency
procedures or clinical follow-up and limit survival.

- Persistent shock or hypotension (e.g. systolic blood pressure less than or equal to
99 mm mercury) that is unresponsive to less than or equal to 6 units of packed red
blood cell (RBC) transfusions or requires continuous intravenous infusions of
vasoactive drugs for blood pressure elevation.

- Severe coagulopathy unresponsive to blood transfusions e.g. international normalized
ratio (INR) > 2.0, platelet count < 20,000, activated partial thromboplastin time
(APTT) greater than 2.0 x normal, or bleeding time > 10 minutes.

- Contraindication to urgent endoscopy or follow-up procedures.
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