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Completed

NCT Number: NCT04024709

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric Peroral Endoscopic Myotomy

Procedure

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.

Primary outcomes

  1. Clinical success of G-POEM

    Time frame: 1 year

    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.

Secondary outcomes

  1. Incidence of adverse events of pylorotomy

    Time frame: 2 years

    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. Clinical success of G-POEM

    Time frame: 2 years

    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.

  3. Delayed gastric emptying after the procedure

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2019
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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