Table 2

Primary treatment success comparison G-POEM versus sham at 6 months and predictors of treatment success at 6 months

VariableOR*95% CI for OR*P value
Allocation G-POEM9.02.0 to 40.20.005
Gender male4.01.0 to 15.8
Age >47 years0.690.19 to 2.52
Baseline GCSI > to 16.4
Baseline GES 4 hours >20 %0.240.06 to 0.93
Baseline distensibility (DI) >8 mm2/mm Hg†3.60.5 to 33.6
Post G-POEM distensibility (DI) >13 mm2/mm Hg‡6.00.66 to 136.8
  • Each variable was tested as a predictor of treatment success in a separate logistic regression model. Only one p value for the main outcome is presented. The analyses of distensibility were performed on available data with N=19 for baseline distensibility and N=16 for post G-POEM distensibility. The remaining analyses used the ITT population with N=41, one treatment success value was imputed and there were no missing data in the predictor variables.

  • *Single parameter statistical significance can be judged by the CI for OR lying entirely below (reduced chance of treatment success) or above (increased chance for treatment success) the value of 1.

  • †Includes sham patients who did not undergo cross-over G-POEM, data for 40 mL filling.

  • ‡Primary G-POEM and cross-over G-POEM combined, data for 40 mL filling.

  • DI, Distensibility Index (Endoflip measurement); GCSI, Gastroparesis Cardinal Symptom Index; G-POEM, endoscopic pyloromyotomy; ITT, intention to treat.