RecruitingNCT06068127

G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through

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


Sponsor

Institute for Clinical and Experimental Medicine

Enrollment

30 participants

Start Date

Oct 12, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a procedure called G-POEM (gastric peroral endoscopic myotomy) — a minimally invasive endoscopic technique — for treating severe gastroparesis (a condition where the stomach empties too slowly) that develops after esophageal surgery (esophagectomy with gastric pull-through). **You may be eligible if...** - You had an esophagectomy (esophagus removal) with a gastric pull-through procedure - You developed gastroparesis afterward and had G-POEM done to treat it - You have at least 6 months of follow-up data after the G-POEM procedure - Your gastroparesis symptoms scored at least 1.0 on a standard symptom scale (GCSI) **You may NOT be eligible if...** - You have a physical blockage (obstruction) at the pylorus (the stomach's outlet) - You do not have at least 6 months of follow-up after G-POEM Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Institute for Clinical and Experimental Medicine

Prague, Czechia

Hôpital Nord

Marseille, France

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NCT06068127


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