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

Institute for Clinical and Experimental Medicine

Status: Enrolling

Conditions: Esophageal Cancer; Gastroparesis

Study type: Observational

Funder types: Other

Identifiers

NCT06068127

GESOM

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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