Gastroparesis
Conditions
Brief summary
This study is looking at how safe and effective G-POEM, GES and a combination of both are for people with severe stomach problems (gastroparesis) that haven't gotten better with medicine.
Interventions
DEVICEGES + Upper endoscopy
Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
DEVICEGES on + Upper endscopy
Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will stay on for the first 6 months and will then be turned off for the following 6 months.
PROCEDUREGES off + G-POEM
Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM surgery. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
PROCEDUREGES on + G-POEM
Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM. POEM. The stimulator will stay on for the first 6 months and will then be turned on for the following 6 months.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients of age 18 years and older * Patients must be able to consent * Documented diagnosis of refractory GP as determined by the following criteria: * Medically refractory GP symptoms for \> 1 year despite treatment with first-line modalities and pharmacotherapies with anti-emetics and prokinetics AND * Gastric emptying scintigraphy showing delayed gastric emptying with retention of \>60% at 2h and/or greater than 10% at 4h based on standardized radionuclide solid meal test * Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score * A decision to treat patient with surgical therapy of G-POEM and/or electric stimulator
Exclusion criteria
* Patients with prior surgical intervention for gastroparesis * Patients less than 18 years old * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastroparesis Symptom Changes | Baseline, Preoperative 3 months, 6 months, 9 months, 12 months | Monitoring changes in gastroparesis symptom severity as measured by the Gastroparesis Cardinal Symptom Index (GCSI). A 9-item patient reported questionnaire with a rating scale of 0-5 ranging from 0 (none) to 5 (very severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects quality of life | Baseline, 6 months, 12 months. | Measuring changes to Quality of Life as measured by the 36-Item Short Form Survey (SF-36). A self-reported tool consisting of 36 questions with a rating scale of 0 (worst health) to 100 (best health). |
| Weight | Baseline, 6 months, 12 months | Assessing changes in weight using clinical measurement |
| BMI | Baseline, 6 months, 12 months | Assessing changes in BMI using clinical measurement |
| Nutritional Support Status | Baseline, 6 months, 12 months | Assessing for need for tube feeds/TPN by referring to subjects medical records |
| Gastroparesis-related hospitalizations | 12 month follow-up | Evaluating rates of reintervention/hospitalizations due to surgical complications by referring to subjects medical records |
| ED visits for symptoms | 12 month follow-up | Evaluating number of ED visits, hospitalizations/readmissions due to gastroparesis by referring to subjects medical records |
| Gastric Emptying | Baseline, 6 months, 12 months | Evaluating gastric emptying as shown in 4-hour retention on gastric emptying scintigraphy using the nuclear medicine report |
| Antiemetic/Prokinetic use | Baseline, 6 months, 12 months | Evaluating changes to pharmacologic use by monitoring active medication use via subjects medical records |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarc Ward, MD
Baylor Health Care System
Outcome results
None listed