Assessing G-POEM effectiveness for gastroparesis after esophagectomy
Retrospective Study of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis After Esophagectomy With Gastric Pull-through
This study is testing whether a procedure called G-POEM can help people with gastroparesis feel better after having surgery to remove part of their esophagus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 2 sites (Prague and 1 other locations) |
| Trial ID | NCT06068127 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of endoscopic pyloromyotomy (G-POEM) in patients experiencing gastroparesis or delayed gastric emptying following esophagectomy with gastric pull-through. It involves multiple European centers that routinely perform G-POEM, collecting data from patients treated since 2015 until December 2023. The study aims to include patients who meet specific inclusion criteria and will analyze their symptomatic responses at 6, 12, and 24 months post-procedure using the Gastroparesis Cardinal Symptom Index (GCSI) score.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone G-POEM after esophagectomy with confirmed or presumed gastroparesis.
Not a fit: Patients with organic pyloric obstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment options for patients suffering from refractory gastroparesis after esophagectomy.
How similar studies have performed: While this approach has been used in other contexts, this specific subgroup analysis of G-POEM in post-esophagectomy patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 1.0. * At least 6 months follow-up after G-POEM. Exclusion Criteria: * Organic pyloric obstruction
Where this trial is running
Prague and 1 other locations
- Institute for Clinical and Experimental Medicine — Prague, Czechia (Recruiting)
- Hôpital Nord — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Rastislav Husťak, PhD, MD
- Email: rastislav.hustak@fntt.sk
- Phone: 00421335938810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.