An observational study in Occult GI Bleeding, sponsored by US Department of Veterans Affairs. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-20.
Sponsored by US Department of Veterans Affairs · Observational
This study is a prospective evaluation of patients with occult (hidden) GI bleeding without iron deficiency. Such patients usually undergo a diagnostic colonoscopy as a standard of care. The study is aimed to determine any UGI-source of occult bleeding and to correlate UGI symptoms with findings. Therefore, EGD is being offered to such patients as part of research. We proposed to enroll 200 consecutive patients referred to our GI-unit for expedited diagnostic colonoscopy for positive FOBT.
Occult gastrointestinal bleeding is defined as iron deficiency or fecal occult blood test (FOBT) positivity with or without anemia. Colonoscopy can detect significant pathology such as colon cancer, significant precancerous polyps, or angiodysplasia. EGD can detect pathology such as esophageal or gastric cancer, peptic ulcer disease, or vascular lesions. Here at the VA, uncomplicated referrals for occult bleeding with anemia are directly schedule for EGD and colonoscopy on the same day without prior clinic visit. Cases of FOBT positivity without anemia or upper GI symptoms usually receive only colonoscopy. Both procedures are standard of care for occult bleeding and have well established safety. The diagnostic yield of bidirectional endoscopy for occult bleeding has previously been studied with mixed results due to the variability in study design, inclusion/exclusion criteria, etc. It is unclear if presentation (iron deficiency vs fobt positivity), severity (level of iron deficiency, hct, transfusion needed), medical history (renal failure, need for Aspirin or NSAIDs etc), or symptoms (upper vs lower GI) are predictive of endoscopic findings. Of particular uncertainty is the utility of upper endoscopy in patients with isolated FOBT positivity (no iron deficiency, anemia, or upper GI symptoms). In a large retrospective study of asymptomatic patients who underwent EGD following a negative colonoscopy performed for FOBT positivity without iron deficiency (with or without anemia) showed that anemia was predictive of significant positive findings (29% vs. 8%). In a prospective study, patients with FOBT positivity without iron deficiency had same bidirectional endoscopy performed. Significant upper gi lesions were more prevalent than colonic lesions (28.6% vs. 21.8%) with a low sensitivity for predicting findings based on symptoms.
Our primary purpose is to determine if anemia or upper GI symptoms can accurately predict the presence of significant upper GI findings in patients with fobt positivity and a non-diagnostic colonoscopy. We will use this information to justify or change our current endoscopic approach to such patients.
Methods:
Study size: 200 consecutive patients
Inclusion criteria:
Outpatients referred for occult bleeding (iron deficiency or fobt positivity)
Exclusion criteria:
Overt bleeding (melena, hematochezia) Abnormal luminal imaging Prior EGD or colonoscopy within 1 year
Study flow:
Results/analysis:
EGD and colonoscopy findings will be recorded and lesions will be categorized as potential bleeding source (PBS) based on criteria outlined by others.
The data will be analyzed for diagnostic yield and statistical tests will be applied as needed to assess for predictors of positive findings.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 893 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients referred for GI consult due to occult bleeding (iron deficiency or FOBT positivity)
Exclusion Criteria:
to determine if anemia or upper gi symptoms can accurately predict the presence of significant upper gi findings in patients with fobt positivity and a non-diagnostic colonoscopy.
Time frame: Baseline
This study is terminated, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs