跳至主要内容
临床试验/NCT06068127
NCT06068127招募中不适用

Retrospective Study of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis After Esophagectomy With Gastric Pull-through

Institute for Clinical and Experimental Medicine2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2023年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
GCSI score

研究概览

简要总结

This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM.

The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure.

For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.

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

入选标准

  • Patients who underwent G-POEM after esophagectomy with a gastric pull-through for confirmed (scintigraphy or breath test) or presumed gastroparesis. (Some centres perform G-POEM in patients whose gastroparesis was not confirmed by a scintigraphy or a breath test, therefore it is only presumed. This particular subset of patients will be analysed separately.)
  • Total GCSI score before G-POEM at least 1.
  • At least 6 months follow-up after G-POEM.

排除标准

  • Organic pyloric obstruction

结局指标

主要结局

GCSI score

时间窗: At baseline and 3, 6, 12, 24, 36 months after G-POEM

Gastroparesis Cardinal Symptom Index questionnaire: The score ranges from 0 to 5 for each symptom (9 questions) and these are averaged into subscores and into a total score (also ranging from 0 to 5). Higher scores indicate more severe symptoms.

次要结局

  • Gastric emptying by scintigraphy(At baseline and 3, 6, 12, 24, 36 months after G-POEM)
  • Gastric emptying by breath test(At baseline and 3, 6, 12, 24, 36 months after G-POEM)
  • Pyloric distensibility(At baseline and 3, 6, 12, 24, 36 months after G-POEM)

研究者

发起方
Institute for Clinical and Experimental Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF

Prof. Jan Martínek, MD, PhD, AGAF

Institute for Clinical and Experimental Medicine

研究点 (2)

Loading locations...

相似试验