Choosing An Optimal Tool for Monitoring Clinical Response in Gastroparesis After Gastric Peroral Endoscopic Pyloromyotomy: A Correlational Study Between Gastric Emptying Scintigraphy and Patient Reported Outcomes: 828

Introduction: Gastroparesis is a debilitating disease with a complex pathophysiology, chronic, relapsing course, rendering inconsistent responses to available treatments. Gastric Per Oral Endoscopic Pyloromyotomy (GPOEM) is a novel endoscopic procedure with exciting potential to become the forefront of gastroparesis treatment. However, one of the challenges in managing gastroparesis is the lack of standardized monitoring tools. This study aims to assess this critical aspect of outcome evaluation by comparing patient-reported clinical metrics and gastric emptying scintigraphy (GES).Figure: Improvement of GCSI after GPOEM during a 12-month follow upFigure: Correlation between GES and patient-reported outcomes as measured by GCSI and SF36;GCSI: gastroparesis cardinal symptoms index; GPOEM: gastric per oral endoscopic pyloromyotomy; SF36: Short form 36; GES: gastric emptying scintigraphy; QoL: quality of life; K-correlation: kappa correlation.Figure: Correlation between patient reported outcomes (GCSI and SF36) after GPOEM; GCSI: gastroparesis cardinal symptoms index; GPOEM: gastric per oral endoscopic pyloromyotomy; SF36: Short form 36; K-correlation: kappa correlation.Methods: This is a retrospective correlational study on outcomes of GPOEM performed from June 2015 to February 2017. GES was obtained at baseline and at 8-week post procedure. Agreements among GES, gastroparesis cardinal symptoms index (GCSI), and quality of life, measured by standardized short-form 36 (SF36) at 1, 6, and 12-month post GPOEM were evaluated. Results: 28 patients with refractory gastroparesis were included. Mean gastric retention at 4-hour GES significantly decreased from baseline of 63.0+/-25.2% to 22.2+/-20.5% (p50% reduction) in 78.3% and has normalized in 47.8% of patients, while GCSI has improved in 76.6%, 80%, and 72.7% of patients at 1, 6, and 12-month post-GPOEM, respectively. Improvement of GES had moderate agreement with both GCSI and SF36 at 1 month post-procedure (K=0.49+/-0.2 and K=0.48+/-0.25). The strength of agreement between GES and SF36 (good agreement at both 6-month and 12-month; K=0.76+/-0.22 and K=0.6+/-0.23) appeared to be better compared to agreement between GES and GCSI (fair agreement K=0.39+/-0.24 at 6-month and moderate agreement K=0.42+/-0.3 at 12-month). Between patient-reported outcomes, GCSI had moderate agreement with SF36 at 1-month and 6-month (K=0.57+/-0.19 and K=0.6+/-0.24) and good agreement at 12-months (K=0.6+/-0.2, 95%CI 0.15-1.0). Conclusion: The inconsistent correlations between GES and patient-reported outcomes found in our study questioned the validity of GES to predict clinical response to gastroparesis treatment. As symptomatic improvement is the main goal of therapy, the role of GES for disease monitoring is unclear and should be used as a reference. With moderate-to-good agreement between GCSI and SF36 and the fact that they were designed to assess different clinical parameters, we believe that both scoring tools are equally important and should be adopted in assessment of therapeutic efficacy of gastroparesis.