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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | GES off + Upper Endoscopy |
|
| GES only | Active Comparator | GES on + Upper Endoscopy |
|
| G-POEM only | Active Comparator | GES off + GPOEM |
|
| Combination G-POEM and GES | Active Comparator | GES on + GPOEM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GES + Upper endoscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Symptom Changes | 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). | Baseline, Preoperative 3 months, 6 months, 9 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects quality of life | 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). | Baseline, 6 months, 12 months. |
| Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Ward, MD | Baylor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D005773 | Gastroscopy |
| D000074882 | Pyloromyotomy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| GES on + Upper endscopy | Device | 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. |
|
| GES off + G-POEM | Procedure | 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. |
|
| GES on + G-POEM | Procedure | 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. |
|
Assessing changes in weight using clinical measurement |
| Baseline, 6 months, 12 months |
| BMI | Assessing changes in BMI using clinical measurement | Baseline, 6 months, 12 months |
| Nutritional Support Status | Assessing for need for tube feeds/TPN by referring to subjects medical records | Baseline, 6 months, 12 months |
| Gastroparesis-related hospitalizations | Evaluating rates of reintervention/hospitalizations due to surgical complications by referring to subjects medical records | 12 month follow-up |
| ED visits for symptoms | Evaluating number of ED visits, hospitalizations/readmissions due to gastroparesis by referring to subjects medical records | 12 month follow-up |
| Gastric Emptying | Evaluating gastric emptying as shown in 4-hour retention on gastric emptying scintigraphy using the nuclear medicine report | Baseline, 6 months, 12 months |
| Antiemetic/Prokinetic use | Evaluating changes to pharmacologic use by monitoring active medication use via subjects medical records | Baseline, 6 months, 12 months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D005743 | Gastrectomy |
| D000074433 | Myotomy |