Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Procedure: Gastric Peroral Endoscopic Myotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: treatment by G-POEM during the study period, at least a 1-year follow-up, and GCSI evaluation before and 1 year after G-POEM. Exclusion Criteria: missing GCSI before and/or 12 months after G-POEM, non-pathological GES before G-POEM: delayed gastric emptying was defined as t ½ > 113 min and %H4 retention > 10%, and loss to follow-up or death before 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Gastric Peroral Endoscopic Myotomy|Creation by submucosal dissection of a tunnel in the gastric wall at the level of the antrum, then of a pyloric and antral myotomy, before closing the mucosal access by clips.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success of G-POEM | evaluate the clinical success at the 1-year follow-up, defined by a decrease in the GCSI score by at least 1 point compared to baseline. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events of pylorotomy | analysis of adverse events during the two years following the pylorotomy (including perforation per-gesture, bleeding post-gesture). ASGE lexicon will be used to grade these adverse events | 2 years | 
| Clinical success of G-POEM | evaluate the clinical success at the 1-year follow-up, defined by a decrease in the Gastroparesis Cardinal Symptoms Index score by at least 1 point compared to baseline. GCSI is a Likert scale ranging from 0 to 5 (5 being the worst 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. | 2 years | 
| Delayed gastric emptying after the procedure | 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). Percent retention at 2hours and 4hours will be compared before and after the procedure. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G-POEM, gastroparesis, POP, oral endoscopic pyloromyotomy