G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through (GESOM)
Retrospective Study of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis After Esophagectomy With Gastric Pull-through
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rastislav Husťak, PhD, MD
- Phone Number: 00421335938810
- Email: rastislav.hustak@fntt.sk
Study Locations
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Prague, Czechia, 14021
- Recruiting
- Institute for Clinical and Experimental Medicine
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Contact:
- Jan Martínek, MD
- Email: homa@ikem.cz
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Marseille, France
- Recruiting
- Hôpital Nord
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Contact:
- Jean-Michel Gonzalez, PhD
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Contact:
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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GCSI score
Time Frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
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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.
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At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric emptying by scintigraphy
Time Frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Gastric scintigraphy protocol endorsed by both American Neurogastroenterology and Motility Society and American Nuclear Medicine Society will be used to assess gastric emptying with a standard 200 kcal, 2% fat egg-substitute test meal.
Gamma camera images will be obtained immediately after meal ingestion and then at 1, 2, 3 and 4 hours.
Diagnostic criterion for delayed gastric emptying is defined as the percentage of gastric retention >60% at 2 h or ≥ 10% at 4 h or both.
Half-time (T1/2) emptying time will also be calculated.
At least 72 hours before gastric emptying test, narcotics and other medications that can interfere with gastric emptying will be discontinued.
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At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Gastric emptying by breath test
Time Frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Gastric emptying assessed using 13C breath test with octanoic acid.
This measurement is an alternative to the measurement of gastric emptying by scintigraphy.
The choice depends on the practice in a particular center.
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At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Pyloric distensibility
Time Frame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
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At baseline and 3, 6, 12, 24, 36 months after G-POEM
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GESOM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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