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

Last updated: March 14, 2024
Sponsor: Institute for Clinical and Experimental Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroparesis

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT06068127
GESOM
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients who underwent G-POEM after esophagectomy with a gastric pull-through forconfirmed (scintigraphy or breath test) or presumed gastroparesis. (Some centresperform G-POEM in patients whose gastroparesis was not confirmed by a scintigraphy ora breath test, therefore it is only presumed. This particular subset of patients willbe analysed separately.)
  • Total GCSI score before G-POEM at least 1.0.
  • At least 6 months follow-up after G-POEM.

Exclusion

Exclusion Criteria:

  • Organic pyloric obstruction

Study Design

Total Participants: 30
Study Start date:
October 12, 2023
Estimated Completion Date:
March 22, 2024

Connect with a study center

  • Institute for Clinical and Experimental Medicine

    Prague, 14021
    Czechia

    Active - Recruiting

  • Hôpital Nord

    Marseille,
    France

    Active - Recruiting

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