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

Esophageal Cancer Clinical Trial

— GESOM  

Official title:

Retrospective Study of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis After Esophagectomy With Gastric Pull-through

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068127
• Other study ID #: GESOM
• Status: Recruiting
• Start date: October 12, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Institute for Clinical and Experimental Medicine
• Contact: Rastislav Hustak, PhD, MD
• Phone: 00421335938810
• Email: rastislav.hustak[@]fntt.sk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastroparesis

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague
France	Hôpital Nord	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Countries where clinical trial is conducted

Czechia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GCSI score	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.	At baseline and 3, 6, 12, 24, 36 months after G-POEM
Secondary	Gastric emptying by scintigraphy	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.	At baseline and 3, 6, 12, 24, 36 months after G-POEM
Secondary	Gastric emptying by breath test	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.	At baseline and 3, 6, 12, 24, 36 months after G-POEM
Secondary	Pyloric distensibility	Pyloric distensibility measured by impedance planimetry (EndoFLIP device)	At baseline and 3, 6, 12, 24, 36 months after G-POEM