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Trial Title:
G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through
NCT ID:
NCT06068127
Condition:
Gastroparesis
Esophageal Cancer
Conditions: Official terms:
Gastroparesis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute for Clinical and Experimental Medicine
Address:
City:
Prague
Zip:
14021
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jan Martínek, MD
Email:
homa@ikem.cz
Facility:
Name:
Hôpital Nord
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Michel Gonzalez, PhD
Contact backup:
Email:
Jean-michel.GONZALEZ@ap-hm.fr
Start date:
October 12, 2023
Completion date:
March 22, 2024
Lead sponsor:
Agency:
Institute for Clinical and Experimental Medicine
Agency class:
Other
Source:
Institute for Clinical and Experimental Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068127
