Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis

Allen A. Lee; Satish Sanku Chander Rao; Linda A. Nguyen; Baharak Moshiree; I. Sarosiek; Michael I. Schulman; John M. Wo; Henry P. Parkman; Gregory E. Wilding; Richard W. McCallum; William L. Hasler; Braden Kuo

doi:10.1016/j.cgh.2018.11.063

Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis

Allen A. Lee, Satish Sanku Chander Rao, Linda A. Nguyen, Baharak Moshiree, I. Sarosiek, Michael I. Schulman, John M. Wo, Henry P. Parkman, Gregory E. Wilding, Richard W. McCallum, William L. Hasler, Braden Kuo

Gastroenterology

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

Abstract

Background & Aims: It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless motility capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods: We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results: Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P < .001). A higher proportion of subjects with diabetes had delayed gastric emptying detected by GES (41.7%) compared with non-diabetic subjects (17.1%) (P=.002). Severe delays in gastric emptying were observed in a higher proportion of subjects by WMC (13.8%) than by GES (6.9%) (P = .02). Rapid gastric emptying was detected in a higher proportion of subjects by GES (13.8%) than by WMC (3.3%) (P < .001). Regional and generalized transit abnormalities were observed in 61.8% subjects and only detected by WMC. Conclusion: Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826.

Original language	English (US)
Pages (from-to)	1770-1779.e2
Journal	Clinical Gastroenterology and Hepatology
Volume	17
Issue number	9
DOIs	https://doi.org/10.1016/j.cgh.2018.11.063
State	Published - Aug 2019

Keywords

Colonic Transit
Gastrointestinal Motility
Idiopathic
Small Bowel Transit

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.1016/j.cgh.2018.11.063

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Lee, A. A., Rao, S. S. C., Nguyen, L. A., Moshiree, B., Sarosiek, I., Schulman, M. I., Wo, J. M., Parkman, H. P., Wilding, G. E., McCallum, R. W., Hasler, W. L., & Kuo, B. (2019). Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis. Clinical Gastroenterology and Hepatology, 17(9), 1770-1779.e2. https://doi.org/10.1016/j.cgh.2018.11.063

Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis. / Lee, Allen A.; Rao, Satish Sanku Chander; Nguyen, Linda A.; Moshiree, Baharak; Sarosiek, I.; Schulman, Michael I.; Wo, John M.; Parkman, Henry P.; Wilding, Gregory E.; McCallum, Richard W.; Hasler, William L.; Kuo, Braden.

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 9, 08.2019, p. 1770-1779.e2.

Research output: Contribution to journal › Article › peer-review

Lee, AA, Rao, SSC, Nguyen, LA, Moshiree, B, Sarosiek, I, Schulman, MI, Wo, JM, Parkman, HP, Wilding, GE, McCallum, RW, Hasler, WL & Kuo, B 2019, 'Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis', Clinical Gastroenterology and Hepatology, vol. 17, no. 9, pp. 1770-1779.e2. https://doi.org/10.1016/j.cgh.2018.11.063

Lee, Allen A. ; Rao, Satish Sanku Chander ; Nguyen, Linda A. ; Moshiree, Baharak ; Sarosiek, I. ; Schulman, Michael I. ; Wo, John M. ; Parkman, Henry P. ; Wilding, Gregory E. ; McCallum, Richard W. ; Hasler, William L. ; Kuo, Braden. / Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis. In: Clinical Gastroenterology and Hepatology. 2019 ; Vol. 17, No. 9. pp. 1770-1779.e2.

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title = "Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis",

abstract = "Background & Aims: It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless motility capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods: We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results: Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P < .001). A higher proportion of subjects with diabetes had delayed gastric emptying detected by GES (41.7%) compared with non-diabetic subjects (17.1%) (P=.002). Severe delays in gastric emptying were observed in a higher proportion of subjects by WMC (13.8%) than by GES (6.9%) (P = .02). Rapid gastric emptying was detected in a higher proportion of subjects by GES (13.8%) than by WMC (3.3%) (P < .001). Regional and generalized transit abnormalities were observed in 61.8% subjects and only detected by WMC. Conclusion: Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826.",

keywords = "Colonic Transit, Gastrointestinal Motility, Idiopathic, Small Bowel Transit",

author = "Lee, {Allen A.} and Rao, {Satish Sanku Chander} and Nguyen, {Linda A.} and Baharak Moshiree and I. Sarosiek and Schulman, {Michael I.} and Wo, {John M.} and Parkman, {Henry P.} and Wilding, {Gregory E.} and McCallum, {Richard W.} and Hasler, {William L.} and Braden Kuo",

note = "Funding Information: The authors thank Dr Richard Krause for his assistance in the conduct of this study as well as Mathilde Lourde, Senior Biostatistician Medtronic, for her assistance with statistical analyses for this manuscript. Research support for this study was provided by Medtronic. Conflicts of interest These authors disclose the following: Satish Rao, Richard McCallum, William Hasler, and Braden Kuo received research grant support from Medtronic. Baharak Moshiree has received research or other support from Medtronic, Cystic Fibrosis Foundation, Allergan, Cairn Diagnostics, Shire/Takeda, Ironwood, Urovant, Prometheus Lab, Ferring, and Shire. She has also engaged as a speaker for Synergy, Medtronic, Nestle Science Institute, and Focus Medical. Irene Sarosiek, Gregory Wilding, and Braden Kuo serve as consultants for Medtronic. The remaining authors disclose no conflicts. Funding Supported by a grant from Medtronic. Funding Information: Conflicts of interest These authors disclose the following: Satish Rao, Richard McCallum, William Hasler, and Braden Kuo received research grant support from Medtronic. Baharak Moshiree has received research or other support from Medtronic, Cystic Fibrosis Foundation, Allergan, Cairn Diagnostics, Shire/Takeda, Ironwood, Urovant, Prometheus Lab, Ferring, and Shire. She has also engaged as a speaker for Synergy, Medtronic, Nestle Science Institute, and Focus Medical. Irene Sarosiek, Gregory Wilding, and Braden Kuo serve as consultants for Medtronic. The remaining authors disclose no conflicts. Publisher Copyright: {\textcopyright} 2019 AGA Institute",

year = "2019",

month = aug,

doi = "10.1016/j.cgh.2018.11.063",

language = "English (US)",

volume = "17",

pages = "1770--1779.e2",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders Ltd",

number = "9",

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TY - JOUR

T1 - Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis

AU - Lee, Allen A.

AU - Rao, Satish Sanku Chander

AU - Nguyen, Linda A.

AU - Moshiree, Baharak

AU - Sarosiek, I.

AU - Schulman, Michael I.

AU - Wo, John M.

AU - Parkman, Henry P.

AU - Wilding, Gregory E.

AU - McCallum, Richard W.

AU - Hasler, William L.

AU - Kuo, Braden

N1 - Funding Information: The authors thank Dr Richard Krause for his assistance in the conduct of this study as well as Mathilde Lourde, Senior Biostatistician Medtronic, for her assistance with statistical analyses for this manuscript. Research support for this study was provided by Medtronic. Conflicts of interest These authors disclose the following: Satish Rao, Richard McCallum, William Hasler, and Braden Kuo received research grant support from Medtronic. Baharak Moshiree has received research or other support from Medtronic, Cystic Fibrosis Foundation, Allergan, Cairn Diagnostics, Shire/Takeda, Ironwood, Urovant, Prometheus Lab, Ferring, and Shire. She has also engaged as a speaker for Synergy, Medtronic, Nestle Science Institute, and Focus Medical. Irene Sarosiek, Gregory Wilding, and Braden Kuo serve as consultants for Medtronic. The remaining authors disclose no conflicts. Funding Supported by a grant from Medtronic. Funding Information: Conflicts of interest These authors disclose the following: Satish Rao, Richard McCallum, William Hasler, and Braden Kuo received research grant support from Medtronic. Baharak Moshiree has received research or other support from Medtronic, Cystic Fibrosis Foundation, Allergan, Cairn Diagnostics, Shire/Takeda, Ironwood, Urovant, Prometheus Lab, Ferring, and Shire. She has also engaged as a speaker for Synergy, Medtronic, Nestle Science Institute, and Focus Medical. Irene Sarosiek, Gregory Wilding, and Braden Kuo serve as consultants for Medtronic. The remaining authors disclose no conflicts. Publisher Copyright: © 2019 AGA Institute

PY - 2019/8

Y1 - 2019/8

N2 - Background & Aims: It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless motility capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods: We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results: Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P < .001). A higher proportion of subjects with diabetes had delayed gastric emptying detected by GES (41.7%) compared with non-diabetic subjects (17.1%) (P=.002). Severe delays in gastric emptying were observed in a higher proportion of subjects by WMC (13.8%) than by GES (6.9%) (P = .02). Rapid gastric emptying was detected in a higher proportion of subjects by GES (13.8%) than by WMC (3.3%) (P < .001). Regional and generalized transit abnormalities were observed in 61.8% subjects and only detected by WMC. Conclusion: Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826.

AB - Background & Aims: It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless motility capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. Methods: We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Results: Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P < .001). A higher proportion of subjects with diabetes had delayed gastric emptying detected by GES (41.7%) compared with non-diabetic subjects (17.1%) (P=.002). Severe delays in gastric emptying were observed in a higher proportion of subjects by WMC (13.8%) than by GES (6.9%) (P = .02). Rapid gastric emptying was detected in a higher proportion of subjects by GES (13.8%) than by WMC (3.3%) (P < .001). Regional and generalized transit abnormalities were observed in 61.8% subjects and only detected by WMC. Conclusion: Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826.

KW - Colonic Transit

KW - Gastrointestinal Motility

KW - Idiopathic

KW - Small Bowel Transit

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ER -

Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis

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