Don Rockey M.D.
Division of Liver and Digestive Diseases
Occult Gastrointestinal Bleeding caused by Portal Hypertensive Gastropathy in Patients with Cirrhosis
Purpose: hypothesis and aims
Our hypothesis is that: (1) Portal Hypertensive Gastropathy (PHG) is a frequent
and significant cause of Occult Gastrointestinal Bleeding (OGIB) in patients
with cirrhosis, and (2) OGIB develops frequently in patients with PHG.
Our aims are: (1) To determine if PHG is a significant cause of OGIB in patients
with cirrhosis, (2) To determine the frequency of PHG in patients with OGIB
and cirrhosis, (3) To determine the incidence of OGIB in patients with PHG and
cirrhosis, (4) To quantify gastrointestinal (GI) blood loss in patients with
cirrhosis using Hemoquant assay.
Background
Occult GastrointestinaI Bleeding (OGIB) represents unrecognized blood loss
from the GI tract without overt signs of bleeding (hematemesis, melena or hematochezia).
It can be identified by a + fecal occult blood test (FOBT) or iron deficiency
anemia (IDA) if it has occurred for a longer period of time. Portal Hypertensive
Gastropathy (PHG) represents changes in the gastric mucosa as a consequence
of portal hypertension. PHG has many endoscopic appearances depending on the
degree of severity, but it is classically recognized as a mosaic like pattern
in the gastric mucosa. PHG is a common finding in patients with cirrhosis and
portal hypertension and has prevalence reported to be as high as 97% in some
series. Natural history studies suggest that PHG may cause acute and/or chronic
GI bleeding in patients with cirrhosis. Such studies report that the incidence
of chronic GI bleeding ranges from 6 to 20% in patients with PHG. In most studies,
the definition of chronic GI bleeding has been based on a decrease in hemoglobin
of 2 g/dL or more in 6 months without evidence of significant overt GI bleeding.
To this point, there have been no studies that have specifically focused on
OGIB, although it appears to be a relatively common finding in patients with
cirrhosis. In addition the design of previous studies did not allow proving
that PHG was a significant cause of chronic GI bleeding.
Therefore, in this study, we would like to determine if PHG is a significant
cause of OGIB in patients with cirrhosis. In addition we would like to quantify
prospectively the amount of blood loss from PHG by measuring the amount of hemoglobin
in stools by the heme-porphyrin test, Hemoquant.
We hypothesize that PHG leads to significant amounts of OGIB and therefore IDA
in patients with cirrhosis.
Concise summary of project:
This study is an observational cross-sectional study. Patients with liver
cirrhosis who meet inclusion criteria (see below) will be asked to participate
in the study. Once subjects agree proper written informed consent and HIPPA
forms will be signed. Patients will undergo the following procedures:
- Blood drawn for hemoglobin and serum ferritin. Blood drawn can be done at
the moment of evaluation in Gastrointestinal laboratory (GI lab), liver clinic
or COPC clinic.
- Previously scheduled upper endoscopy and/or colonoscopy as part of their standard
medical care.
- Formal stool testing using hemoccult and hemoquant will be performed. Patients
will be asked to collect stool samples and to bring it back to the investigator.
These procedures will be perform only one time. No follow up will be needed
as party of this study. Follow up will be done as part of the standard of medical
care.
After all these procedures, we will separate patients into 4 different groups
for further statistical analysis:
- Group 1: patients with OGIB and PHG
- Group 2: patients with OGIB without PHG
- Group 3: patients without OGIB and with PHG
- Group 4: patients without OGIB and without PHG
We anticipate that the identification of these groups of participants will be
beneficial for future studies.