Small Bowel Visualization
Conditions
Brief summary
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.
Interventions
DEVICEovertube use during enteroscopy
use of overtube for the regular scheduled enteroscopy
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects ≥ 18 years. 2. Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel. 3. Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated. 4. Subject must be able to give informed consent.
Exclusion criteria
1. Platelets \< 75,000. 2. INR \> 1.6. 3. NSAIDS within 48 hours of procedure. 4. Pregnancy. 5. Esophageal stricture. 6. Inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Persistent or Recurrent Bleeding | up to 6 yrs after after the endoscopy | The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy. |
Countries
United States
Participant flow
Recruitment details
We started this study in June 2007 and ended this study in Oct 2012. We approached any patient who was scheduled in our endoscopy suite for an overtube enteroscopy.
Pre-assignment details
The only significant event was that the subject was scheduled for an enteroscopy in our facility and a overtube was used at the time of endoscopy.
Participants by arm
| Arm | Count |
|---|---|
| Enteroscopy Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study. | 193 |
| Total | 193 |
Baseline characteristics
| Characteristic | Enteroscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 99 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 193 participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 193 |
| serious Total, serious adverse events | 8 / 193 |
Outcome results
Primary
Number of Patients With Persistent or Recurrent Bleeding
The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.
Time frame: up to 6 yrs after after the endoscopy
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Spiral Enteroscopy Subjects | Number of Patients With Persistent or Recurrent Bleeding | 16 participants | 12.3 |