Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
Status: | Terminated |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 95 |
Updated: | 6/27/2018 |
Start Date: | January 2014 |
End Date: | May 31, 2017 |
Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat
because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is
a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis
and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is
unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to
limited visualization of the small bowel lining during conventional endoscopy. One way to
improve visualization of the small bowel lining is by adding a transparent plastic cap to the
end of the endoscope (camera), which allows the endoscope to see around sharp turned and
behind folds in the small bowel.
The investigators goal in this randomized controlled study is to see if adding a transparent
cap to the end of the endoscope will help to identify and treat small bowel bleeding. The
investigators will invite patients referred for BAE to participate in the study; the
alternative to participating in the study is having standard BAE (without a cap). If patients
choose to participate in the study they will be randomized to BAE with or without a cap on
the end of the endoscope. Subjects time commitment will be limited to the consent process and
pre-procedure paperwork at time of initial endoscopy and time required to complete telephone
questionnaire at 12 months follow up.
because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is
a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis
and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is
unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to
limited visualization of the small bowel lining during conventional endoscopy. One way to
improve visualization of the small bowel lining is by adding a transparent plastic cap to the
end of the endoscope (camera), which allows the endoscope to see around sharp turned and
behind folds in the small bowel.
The investigators goal in this randomized controlled study is to see if adding a transparent
cap to the end of the endoscope will help to identify and treat small bowel bleeding. The
investigators will invite patients referred for BAE to participate in the study; the
alternative to participating in the study is having standard BAE (without a cap). If patients
choose to participate in the study they will be randomized to BAE with or without a cap on
the end of the endoscope. Subjects time commitment will be limited to the consent process and
pre-procedure paperwork at time of initial endoscopy and time required to complete telephone
questionnaire at 12 months follow up.
Inclusion Criteria:
- Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron
deficiency anemia.
Exclusion Criteria:
- Unable to provide written informed consent.
- Pregnancy or lactation.
- Suspected bowel obstruction or GI perforation.
- Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
- Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of
normal).
- Patient undergoing retrograde BAE.
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