The Smart Pill Where Does It Stand In

Objectives • Provide a practical overview of what Smart. Pill® is and how testing

Case 39 yo female post-prandial epigastric discomfort and nausea, abdominal bloating throughout the day.

Smart. Pill® • Wireless motility capsule used in evaluation of gut transit • FDA

Photo credit: http: //www. givenimaging. com/enint/Innovative. Solutions/Motility/Smart. Pill/Pages/default. aspx 26 x 13 mm Photo

Normal Transit Region Gastric Small bowel Colonic Whole gut Time (in hours) 2– 5

Procedure • • • Overnight fast, d/c meds that affect motility/p. H Smart. Bar:

Region Conventional Transit Studies Gastric Scintigraphy, Breath testing, US/MRI Scintigraphy, breath testing, barium studies,

Comparison Data • Gastric emptying scintigraphy – CC: 0. 73 with 4 h, 0.

Clinical Utility • Over one-half with new information provided • Over one-third with delays

Symptom Reporting • Patient-reported symptoms are not predictive of: – Region of delay –

Limitations • Contraindications: pediatrics, suspected P/M obstruction, severe dysphagia, Crohn disease, postop from abdominal

Future Uses • Bloating: 54% with abnormal wireless motility capsule study G: gastric delay

Future Uses • Post-operative ileus • Transit assessments in Crohn Disease • Interventions (lubiprostone,

How to Order • Clinic referral • Direct access – Fax demographic/insurance information and

Take-Home Points • Smart. Pill® is an easily administered test of gastrointestinal transit •

Slides: 18

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The Smart. Pill®… 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 Smart. Pill® is and how testing works. • Discuss approved uses and clinical utility. • Consider limitations and potential future uses.

Case 39 yo 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.

Smart. Pill® • 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/Innovative. Solutions/Motility/Smart. Pill/Pages/default. aspx 26 x 13 mm Photo credit: http: //wakegastro. com/smartpilldiagnostic-tool-assess-gi-function/ Photo credit: Saad RJ. Curr Gastroenterol Rep 2016.

Normal Transit Region Gastric Small bowel Colonic Whole gut Time (in hours) 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/p. H Smart. Bar: 260 k-cal nutrient bar (17% protein, 66% carbs, 2% fat, 3% fiber) + 50 m. L water; consume this then the capsule, then wait 6 h before next meal External recorder stays in place x 3 -5 d, various activities recorded manually; keep within 5 ft of body Patient must refrain from tobacco x 8 h, alcohol x 72 h post-ingestion No vigorous exercise during the study Preparation Hasler WL. Expert Rev Gastroenterol Hepatol 2014.

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 4 h, 0. 63 with 2 h (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 Sci 2015. Kuo B, et al. 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 • Smart. Pill® 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