MedTrace Logo

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

NCT04024709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2019-07-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-04-01
Completion
2019-04-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04024709 on ClinicalTrials.gov