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The SmartPill®…
Where Does It Stand In GI Motility?
Gastroenterology and Hepatology Symposium
February 11, 2017
Reena V. Chokshi, MD
Assistant Professor of Medicine
Division of Gastroenterology, Hepatology, & Nutrition
Department of Internal Medicine
Objectives
• Provide a practical overview of what
SmartPill® is and how testing works.
• Discuss approved uses and clinical utility.
• Consider limitations and potential future uses.
Case
39yo female post-prandial epigastric discomfort and
nausea, abdominal bloating throughout the day. Also
with intermittent constipation that’s not always related
to her pain. Tried dietary changes (GF, dairy-free) and
probiotics, all unsuccessfully. Hesitant to take
medications. CBC/CMP/EGD normal, not sure what to
do next. No significant medical history.
SmartPill®
• Wireless motility capsule used in evaluation of
gut transit
• FDA approval
– 2006: Evaluate those suspected of having delayed
gastric emptying
– 2009: Evaluate colonic transit in patients with
chronic idiopathic constipation
Photo credit: http://www.givenimaging.com/enint/InnovativeSolutions/Motility/SmartPill/Pages/default.aspx
26x13mm
Photo credit: http://wakegastro.com/smartpilldiagnostic-tool-assess-gi-function/
Photo credit: Saad RJ. Curr Gastroenterol Rep 2016.
Normal Transit
Region
Time (in hours)
Gastric
Small bowel
Colonic
Whole gut
2–5
2–6
10 – 59
10 – 73
• Variability
– Females have longer GET/CTT
– Increased age associated with shorter SBTT
Lee YY, et al. J Neurogastroenterol Motil 2014.
Wang YT, et al. Aliment Pharmacol Ther 2015.
Procedure
•
•
•
•
•
Overnight fast, d/c meds that affect
motility/pH
SmartBar: 260 k-cal nutrient bar (17%
protein, 66% carbs, 2% fat, 3% fiber) +
50mL water; consume this then the
capsule, then wait 6h before next meal
External recorder stays in place x 3-5d,
various activities recorded manually; keep
within 5ft of body
Patient must refrain from tobacco x 8h,
alcohol x 72h post-ingestion
No vigorous exercise during the study
Preparation
Hasler WL. Expert Rev Gastroenterol Hepatol 2014.
Case
39yo female post-prandial epigastric discomfort and
nausea, abdominal bloating throughout the day. Also
with intermittent constipation that’s not always related
to her pain. Tried dietary changes (GF, dairy-free) and
probiotics, all unsuccessfully. Hesitant to take
medications. CBC/CMP/EGD normal, not sure what to
do next. No significant medical history.
Region
Conventional Transit Studies
Gastric
Scintigraphy, Breath testing,
US/MRI
Scintigraphy, breath testing,
barium studies, capsule
endoscopy
Scintigraphy, radiopaque
marker testing
Scintigraphy
Small bowel
Colonic
Whole gut
Rao SSC, et al. Neurogastroenterol Motil 2011.
Comparison Data
• Gastric emptying scintigraphy
– CC: 0.73 with 4h, 0.63 with 2h (Kuo B, et al. Aliment Pharmacol Ther
2008)
• Colonic radiopaque markers
– CC: 0.78 with day 2, 0.59 with day 5 (Rao SS, et al. Clin Gastroenterol
Hepatol 2009)
– 87% agreement with 5-day study (Camilleri M, et al.
Neurogastroenterol Motil 2010)
• Whole gut scintigraphy
– CC: 0.79 (Maqbool S, et al. Dig Dis Sci 2009)
Clinical Utility
• Over one-half with new information provided
• Over one-third with delays in multiple regions
Rao SSC, et al. J Clin Gastroenterol 2011.
Kuo B, et al. Dig Dis Sci 2011.
Symptom Reporting
• Patient-reported symptoms are not predictive
of:
– Region of delay
– Single vs. multiple region delay
• Applies to either upper or lower gut
symptoms
Arora Z, et al. Dig Dig Sci 2015.
Kuo B, et al. Dig Dig Sci 2011.
Limitations
• Contraindications: pediatrics, suspected P/M
obstruction, severe dysphagia, Crohn disease, postop from abdominal surgery, need for MRI, PPM
• Failure to transmit data – software malfunction,
equipment failure (~0.8-0.9%)
• Single pressure sensor limits ability to assess
peristaltic wave propagation
• Potential AE: capsule retention, obstruction, inability
to confirm passage
Saad RJ. Curr Gastroenterol Rep 2016.
Future Uses
• Bloating: 54% with abnormal wireless motility
capsule study
G: gastric delay
S: small bowel delay
C: colonic delay
Triadafilopoulos G. BMJ Open Gastroenterol 2016.
Future Uses
• Post-operative ileus
• Transit assessments in Crohn Disease
• Interventions (lubiprostone, caminical)
Vilz TO, et al. BMJ Open 2016.
Yung D, et al. Endosc Int Open 2016.
Christie J, et al. Am J Gastroenterol 2016.
Hobson R, et al. Neurogastroenterol Motil 2015.
How to Order
• Clinic referral
• Direct access
– Fax demographic/insurance information and an
order to our scheduling team
– Contact information on our motility brochure
Take-Home Points
• SmartPill® is an easily administered test of
gastrointestinal transit
• Currently approved for evaluation of delayed gastric
emptying and colonic transit
• Gives comparable results to conventional testing but
is nonradioactive and allows for multiple regions to
be evaluated in a real world setting
• Provides new information in over half of patients,
leading to changes in management