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

NCT06068127 | Recruiting

• 1 other identifier: GESOM
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Gastroparesis; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gastric emptying by scintigraphy

  At baseline and 3, 6, 12, 24, 36 months after G-POEM

• Gastric emptying by breath test

  At baseline and 3, 6, 12, 24, 36 months after G-POEM

• Pyloric distensibility

  At baseline and 3, 6, 12, 24, 36 months after G-POEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Organic pyloric obstruction

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (2)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

RECRUITING

Hôpital Nord

Marseille, France

RECRUITING

MeSH Terms

Conditions

Gastroparesis; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Esophageal Diseases

Central Study Contacts

Rastislav Husťak, PhD, MD

CONTACT

00421335938810; rastislav.hustak@fntt.sk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jan Martínek, MD, PhD, AGAF

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 5, 2023
• Study Start: October 12, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

FR (1); CZ (1)