Gastroparesis Clinical Trial
Official title:
Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis
This is a large multicenter retrospective French cohort conducted in seven French centers
that had performed at least five G-POEM procedures at the end of 2017. All patients treated
by G-POEM for refractory gastroparesis since April 30, 2014 (first case of GPOEM in France)
in these seven centers were included in this study and followed until April 2019. The data
were collected retrospectively regarding medical and technical data, and then prospectively
for the following data, which were included in a database for each center and combined for
analysis.
Gastric Cardinal Symptoms Index (GCSI) was used to evaluate symptoms and their severity. It
applies a Likert scale ranging from 0 to 5 (5 being the highest score) for three subscales:
satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of
two items). The total GCSI score was the mean of the three subscales. A GCSI score ≥ 2.6 is
considered moderate gastroparesis and ≥ 3 is considered severe.
Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is
considered the gold standard according to the American Society of Neurogastroenterology.
Patients consume a radiolabeled meal, receive imaging at specific time-points to determine
gastric retention. The exam is pathological when retention is > 90% after 1 hour, > 60% after
2 hours (H2), > 30% after 3 hours (H3), and > 10% after 4 hours (H4). All but one center
performed the GES according to the US guidelines: that center performed a 3-hour GES with a
local validation of a threshold of 30% retention at H3 to define delayed gastric emptying. A
%H4 retention > 30% was defined as severe delayed gastric emptying.
n/a
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