Clinical trial NCT06068127: G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through
Official title: Retrospective Study of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis After Esophagectomy With Gastric Pull-through
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Esophageal Cancer
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2023-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent G-POEM after esophagectomy with a gastric pull-through in any of the participating centers since January 2015 till December 2023.

Brief 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 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

Primary outcomes:
measure: GCSI score
timeFrame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
Secondary outcomes:
measure: Gastric emptying by scintigraphy
timeFrame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
measure: Gastric emptying by breath test
timeFrame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
measure: Pyloric distensibility
timeFrame: At baseline and 3, 6, 12, 24, 36 months after G-POEM
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Marseille
country: France
facility: Hôpital Nord
Study officials:
References: