NCT04024709

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2019-07-18
• Last updated: 2019-07-18

Locations

7 sites across 1 country: France