Occult GI BleedingNCT00636597
A Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding
An observational study of Occult GI Bleeding, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occult GI Bleeding
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients referred for GI consult due to occult bleeding (iron deficiency or FOBT positivity)
Who may be able to join
- Outpatients referred for occult bleeding (iron deficiency or FOBT positivity)
Who cannot join
- Overt bleeding (melena, hematochezia)
- Abnormal luminal imaging
- Prior EGD or colonoscopy within 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215
About this study
Official title: Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding
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.
Read the detailed 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:
- Review all outpatient referrals for occult bleeding (iron def, fobt positive).
- All potential patients will be contacted by phone and their enrollment/participation will be discussed. If interested we will proceed.
- 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).
- 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.
- 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.
- 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.
- Conditions
- Occult GI Bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startApr 2007
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Not able to find enough eligible patients (200) in last 4 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occult GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shahid Mehboob, MD, Principal investigator, VA Western New York Healthcare System at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636597
- Sponsor's protocol ID
- Buff VAMC 001
- Other IDs
- 00556
- Status last verified
- Oct 2011
- First submitted
- 7 Mar 2008
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding
- ClinicalTrials.gov ID
- NCT00636597
- Acronym / sponsor ID
- Buff VAMC 001
- Conditions
- Occult GI Bleeding
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not able to find enough eligible patients (200) in last 4 years.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Review all outpatient referrals for occult bleeding (iron def, fobt positive).
- All potential patients will be contacted by phone and their enrollment/participation will be discussed. If interested we will proceed.
- 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).
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients referred for GI consult due to occult bleeding (iron deficiency or FOBT positivity)
Key inclusion criteria (1 listed)
- Outpatients referred for occult bleeding (iron deficiency or FOBT positivity)
Key exclusion criteria (3 listed)
- Overt bleeding (melena, hematochezia)
- Abnormal luminal imaging
- Prior EGD or colonoscopy within 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Not able to find enough eligible patients (200) in last 4 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
Related trials for Occult GI Bleeding
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahid Mehboob, MD principal investigator
VA Western New York Healthcare System at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occult GI Bleeding, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not able to find enough eligible patients (200) in last 4 years.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.