Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00636597 |
| Other study ID # |
Buff VAMC 001 |
| Secondary ID |
00556 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
March 7, 2008 |
| Last updated |
October 19, 2011 |
| Start date |
April 2007 |
| Est. completion date |
June 2011 |
Study information
| Verified date |
October 2011 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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:
1. Review all outpatient referrals for occult bleeding (iron def, fobt positive).
2. All potential patients will be contacted by phone and their enrollment/participation
will be discussed. If interested we will proceed.
3. We will confirm/obtain fobtx3, full iron panel (iron, tibc, ferritin), cell count
(including mcv), coags, and creatinine within 1 month of procedure (if not already done
within that time).
4. We will complete a standard questionnaire as outlined below. Date will come from direct
questioning and review of CPRS. This will be done by phone. Questioning will take about
15 minutes. See attached.
5. Once labs and questionnaire are obtained, pts will then be scheduled for same day
colon/egd (with duodenal biopsy regardless of appearance) within 30 days performed by
Dr Baichi or Dr Mehboob. Colonoscopy will be performed first. Egd will be cancelled
only if colon has obvious malignancy. Other positive findings will not eliminate need
for egd.
6. Patient study involvement ends after completion of procedures
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.
