Capsule Endoscopy
Conditions
Keywords
capsule endoscopy, battery life, completion rate, diagnostic yield
Brief summary
Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome. While CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended. This study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield.
Interventions
None listed
Sponsors
University of British Columbia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female age 19 or greater who are referred for small bowel capsule endoscopy * Willing and able to provide written informed consent
Exclusion criteria
* Unwillingness or inability to swallow pill * Known or suspected obstruction or bowel stricture * Endoscopic placement of capsule camera * Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate (Rate at Which Small Bowel is Completely Examined) | 0.1 - 12 hours | rate at which small bowel is completely examined (capsule endoscopy enters cecum) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield | 0.1 - 12 hours | rate at which a pathological finding is identified on capsule endoscopy |
| Gastric Transit Time | 0.1 - 12 hours | time it takes for capsule camera to traverse the stomach |
| Small Bowel Transit Time | 0.1 - 12 hours | times it takes for capsule camera to traverse the entire small bowel. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PillCam SB3EX All participants in the study used the PillCam SB3EX for their capsule endoscopy | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | PillCam SB3EX | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 15 Participants | — |
| Age, Categorical Between 18 and 65 years | 42 Participants | — |
| Age, Continuous | 53.6 years STANDARD_DEVIATION 15.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 57 participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
Primary
Completion Rate (Rate at Which Small Bowel is Completely Examined)
rate at which small bowel is completely examined (capsule endoscopy enters cecum)
Time frame: 0.1 - 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillCam SB3EX | Completion Rate (Rate at Which Small Bowel is Completely Examined) | 57 Participants |
Secondary
Diagnostic Yield
rate at which a pathological finding is identified on capsule endoscopy
Time frame: 0.1 - 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PillCam SB3EX | Diagnostic Yield | 20 Participants |
Secondary
Gastric Transit Time
time it takes for capsule camera to traverse the stomach
Time frame: 0.1 - 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PillCam SB3EX | Gastric Transit Time | 37.6 minutes | Standard Deviation 92.1 |
Secondary
Small Bowel Transit Time
times it takes for capsule camera to traverse the entire small bowel.
Time frame: 0.1 - 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PillCam SB3EX | Small Bowel Transit Time | 232.1 minutes | Standard Deviation 98.3 |