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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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:

  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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00636597
Study groupRoleWhat they receive
1Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted14 Mar 2008 (estimated)
  2. Study startApr 2007
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Not able to find enough eligible patients (200) in last 4 years.

Resources

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)
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

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.

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