Clinical trial NCT02315404: Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
Official title: Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obscure Gastrointestinal Bleeding
Keywords: Obscure gastrointestinal bleeding
Overt gastrointestinal bleeding
Occult gastrointestinal bleeding
Enteroscopy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).
timeFrame: 1 day
Secondary outcomes:
measure: Overall Diagnostic yield of BAE vs. C-BAE
timeFrame: 1 day
measure: Therapeutic yield BAE vs. Cap assisted BAE (C-BAE).
timeFrame: 1 day
measure: iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al.
timeFrame: 1 day
measure: vProcedure related adverse events.
timeFrame: 1 day
measure: Recurrence of GI bleeding at 12 months, as evaluated by questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
Study officials:
References: