Performance characteristics of scintigraphic measurement of gastric emptying of solids in healthy participants

Abstract

Background: Gastric emptying (GE) is measured in pharmacodynamic and diagnostic studies. Our aim was to assess inter- and intra-subject coefficients of variation (COV) of scintigraphic GE measurements in healthy subjects, and associations of GE with gender and body mass index (BMI).

Methods: Data from participants with scintigraphic measurements of gastric emptying of solids were analyzed. Primary endpoints were gastric emptying T(1/2) (GE T(1/2) ) and GE at 1, 2, 3, and 4 h.

Key results: The patient cohort consisted of 105 males and 214 females; at least two studies were performed in 47 subjects [16 males (M), 32 females (F)]. Inter-subject COV (COV(inter) ) for GE T(1/2) were similar in M and F: overall 24.5% (M 26.0%, F 22.5%); COV are predictably lowest for GE at 4 h (COV(inter) 9.6%). COV(intra) for T(1/2) and GE at 4 h were overall 23.8% and 12.6%, and were similar to COV(inter) values. Gender (but not age or BMI) was significantly associated with GE T1/2 [P < 0.001, F 127.6 ± 28.7 (SD) min; M 109.9 ± 28.6 min] and with GE at 1 h and 2 h. Repeat GE T(1/2) values in 47 participants were significantly correlated (r = 0.459, P < 0.001) with median difference of -6 min (mean -1.6, range -56 to 72 min). Bland-Altman plots showed Δ GE T(1/2) similarly distributed across mean GE T(1/2) 100-155 min, and across studies conducted 90-600 days apart.

Conclusions & inferences: Inter-subject variations in scintigraphic GE results are only slightly higher than the intra-subject measurements, which are also reproducible over time in healthy volunteers. Gender, but not BMI, is significantly associated with GE results.

Figure 1

Pearson correlation between first and second measurements of gastric emptying T_1/2.

Figure 2

Bland-Altman plots showing intra-subject variation of gastric emptying T_1/2. Plot shows 1 standard deviation as the interrupted lines. Note most data are well within 1 SD which is 30.6 min.

Figure 3

Bland-Altman plots showing effect of time interval in years between consecutive measurements of gastric emptying T_1/2. There does not appear to be a difference in the variation of gastric emptying when the interval is between 90 and 500 days.

Figure 4

Relationship of body mass index (BMI, left panel), age (right panel) and gastric emptying T_1/2. Note that no significant relationships were identified.