Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 3
- 主要终点
- Clinical success of G-POEM
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Clinical success of G-POEM
时间窗: 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.
次要结局
- Delayed gastric emptying after the procedure(2 years)
- Incidence of adverse events of pylorotomy(2 years)
- Clinical success of G-POEM(2 years)
