Wireless pH-motility capsule for colonic transit

Prospective comparison with radiopaque markers in chronic constipation

M. Camilleri, N. K. Thorne, Y. Ringel, W. L. Hasler, B. Kuo, T. Esfandyari, A. Gupta, S. M. Scott, R. W. McCallum, H. P. Parkman, E. Soffer, G. E. Wilding, J. R. Semler, Satish Sanku Chander Rao

Research output: Contribution to journalArticle

116 Citations (Scopus)

Abstract

Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit. Key Results Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was ∼80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was ∼91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events. Conclusions & Inferences The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation.

Original languageEnglish (US)
JournalNeurogastroenterology and Motility
Volume22
Issue number8
DOIs
StatePublished - Aug 1 2010

Fingerprint

Constipation
Capsules
Colon
Multicenter Studies
Pressure
Equipment and Supplies
Temperature

Keywords

  • colonic transit time
  • correlation
  • negative agreement
  • positive agreement
  • radiopaque markers
  • wireless motility capsule

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

Cite this

Wireless pH-motility capsule for colonic transit : Prospective comparison with radiopaque markers in chronic constipation. / Camilleri, M.; Thorne, N. K.; Ringel, Y.; Hasler, W. L.; Kuo, B.; Esfandyari, T.; Gupta, A.; Scott, S. M.; McCallum, R. W.; Parkman, H. P.; Soffer, E.; Wilding, G. E.; Semler, J. R.; Rao, Satish Sanku Chander.

In: Neurogastroenterology and Motility, Vol. 22, No. 8, 01.08.2010.

Research output: Contribution to journalArticle

Camilleri, M, Thorne, NK, Ringel, Y, Hasler, WL, Kuo, B, Esfandyari, T, Gupta, A, Scott, SM, McCallum, RW, Parkman, HP, Soffer, E, Wilding, GE, Semler, JR & Rao, SSC 2010, 'Wireless pH-motility capsule for colonic transit: Prospective comparison with radiopaque markers in chronic constipation', Neurogastroenterology and Motility, vol. 22, no. 8. https://doi.org/10.1111/j.1365-2982.2010.01517.x
Camilleri, M. ; Thorne, N. K. ; Ringel, Y. ; Hasler, W. L. ; Kuo, B. ; Esfandyari, T. ; Gupta, A. ; Scott, S. M. ; McCallum, R. W. ; Parkman, H. P. ; Soffer, E. ; Wilding, G. E. ; Semler, J. R. ; Rao, Satish Sanku Chander. / Wireless pH-motility capsule for colonic transit : Prospective comparison with radiopaque markers in chronic constipation. In: Neurogastroenterology and Motility. 2010 ; Vol. 22, No. 8.
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abstract = "Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65{\%} for patients who had normal or delayed ROM transit. Key Results Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was ∼80{\%}; positive agreement in 47 by WMC/59 by ROM or 0.796 (95{\%} CI = 0.67-0.98); agreement vs null hypothesis (65{\%}) P = 0.01. The negative percent agreement (normal transit) was ∼91{\%}: 89 by WMC/98 by ROM or 0.908 (95{\%} CI = 0.83-0.96); agreement vs null hypothesis (65{\%}), P = 0.00001. Overall device agreement was 87{\%}. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events. Conclusions & Inferences The 87{\%} overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation.",
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AU - Hasler, W. L.

AU - Kuo, B.

AU - Esfandyari, T.

AU - Gupta, A.

AU - Scott, S. M.

AU - McCallum, R. W.

AU - Parkman, H. P.

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N2 - Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit. Key Results Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was ∼80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was ∼91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events. Conclusions & Inferences The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation.

AB - Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit. Key Results Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was ∼80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was ∼91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events. Conclusions & Inferences The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation.

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