Gastroparesis
Conditions
Keywords
Nausea, Vomiting, Delayed gastric emptying, Diabetes Mellitus, Post-Surgical, Idiopathic
Brief summary
The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.
Detailed description
Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy. The symptoms of GP are nausea, vomiting, anorexia/early satiety, bloating/distention and abdominal pain and are classically associated with delayed gastric emptying of solids. The technique of GES was first used, in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials, particularly the GEMS trial, a feasibility trial starting in 1995 and the WAVESS trial, a double-blind trial begun in 1997. Both were international trials, showing promising results, and both have been published in the last 2 years. However, a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged. Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis, such as post-surgical gastropathy, which is often related to rapid, not delayed gastric emptying could be helped. Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope, combined with an external Gastric Electrical Stimulation device, has been tried and validated, first at UAMS in Little Rock, AR, beginning in 2001 and more recently here at UMMC, beginning later in 2001 and up until the present time. Using the technique of temporary gastric electrical stimulation, we have been able to demonstrate that TempStim can quickly demonstrate (in a manner of days) that a patient will respond to temporary GES, as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying.
Interventions
DEVICEGastric Electrical Stimulator, Enterra, Medtronics, Inc.
All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
Sponsors
Medtronic
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Sex: Male of Female * Age Range: 18 to 70 inclusive * Patients with GP of diabetic, surgically related or idiopathic etiology. * Symptoms of GP for \>/= 1 year. * Refractory or intolerant to antiemetic drug classes (antihistamines and phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists) * Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom irrespective of GET values. * The patient is willing and able to provide informed consent. * The patient is willing and able to return for required follow-up visits.
Exclusion criteria
* Patients \< 18 or \>70 years in age. * Patients with an active infection of any kind. * Patients who the investigator determines are not candidates for endoscopic procedures. * Women who are pregnant * Inability or unwillingness to provide informed consent * Unwilling or unable to return for required follow-up visits and examinations. * Patients who are currently enrolled in another investigation of a medical device or drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom of Vomiting Associated With Gastroparesis | Study Day 0 (Baseline), Day 3, Day 7 | Likert Scale 0-4 (low-high) using a patient reported outcomes tool |
| Symptom of Nausea Associated With Gastroparesis | Study Day 0 (Baseline), Day 3, Day 7 | Likert Scale 0-4 (low-high) using a patient reported outcomes tool |
| Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | Study Day 0 (Baseline), Day 4, Day 8 | Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day. |
Countries
United States
Participant flow
Recruitment details
Patients seeking temporary gastric electric stimulator devices for drug-refractory gastroparesis between August 2005 and October 2006 who met the inclusion criteria and did not have any of the exclusion criteria were offered access to the research protocol.
Pre-assignment details
No significant events or approaches for the overall study following participant enrollment were performed prior to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Gastric Stimactivated Days1-4/Not Activated Days5-8 The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days | 28 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours. | 30 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse event: lead dislodgement. | 6 | 7 |
Baseline characteristics
| Characteristic | Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Gastric Stimactivated Days1-4/Not Activated Days5-8 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 26 Participants | 53 Participants |
| Age Continuous | 47 years STANDARD_DEVIATION 14 | 47 years STANDARD_DEVIATION 13 | 47 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 30 participants | 28 participants | 58 participants |
| Sex: Female, Male Female | 26 Participants | 21 Participants | 47 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 51 | 7 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 |
Outcome results
Primary
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.
Time frame: Study Day 0 (Baseline), Day 4, Day 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 0, at 2nd hour | 69.96 percentage of radiolabeled meal in stoma | Standard Error 23.79 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 4, at 4th hour | 24.11 percentage of radiolabeled meal in stoma | Standard Error 23.76 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 4, at 1st hour | 69.96 percentage of radiolabeled meal in stoma | Standard Error 23.79 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 8, at 1st hour | 64.71 percentage of radiolabeled meal in stoma | Standard Error 21.1 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 0, at 4th hour | 64.71 percentage of radiolabeled meal in stoma | Standard Error 21.1 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 8, at 2nd hour | 42.19 percentage of radiolabeled meal in stoma | Standard Error 24.37 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 4, at 2nd hour | 46.85 percentage of radiolabeled meal in stoma | Standard Error 25.3 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 8, at 4th hour | 24.71 percentage of radiolabeled meal in stoma | Standard Error 27.94 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 0, at 1st hour | 67.07 percentage of radiolabeled meal in stoma | Standard Error 20.23 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 8, at 4th hour | 20.25 percentage of radiolabeled meal in stoma | Standard Error 25.26 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 0, at 1st hour | 66.13 percentage of radiolabeled meal in stoma | Standard Error 25.37 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 0, at 2nd hour | 37.41 percentage of radiolabeled meal in stoma | Standard Error 28.06 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 0, at 4th hour | 16.43 percentage of radiolabeled meal in stoma | Standard Error 23 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 4, at 1st hour | 62.35 percentage of radiolabeled meal in stoma | Standard Error 24.75 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 4, at 2nd hour | 38.00 percentage of radiolabeled meal in stoma | Standard Error 24.64 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 4, at 4th hour | 21.85 percentage of radiolabeled meal in stoma | Standard Error 28.51 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 8, at 1st hour | 68.67 percentage of radiolabeled meal in stoma | Standard Error 19.92 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis | GET Day 8, at 2nd hour | 40.92 percentage of radiolabeled meal in stoma | Standard Error 26.5 |
Primary
Symptom of Nausea Associated With Gastroparesis
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Time frame: Study Day 0 (Baseline), Day 3, Day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Nausea Associated With Gastroparesis | Nause Score Day 0 | 3.27 Patient Self-reported Symptom Score | Standard Error 0.92 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Nausea Associated With Gastroparesis | Nausea Score Day 3 | 1.46 Patient Self-reported Symptom Score | Standard Error 1.29 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Nausea Associated With Gastroparesis | Nausea Score Day 7 | 2.26 Patient Self-reported Symptom Score | Standard Error 1.18 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Nausea Associated With Gastroparesis | Nause Score Day 0 | 3.33 Patient Self-reported Symptom Score | Standard Error 1.03 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Nausea Associated With Gastroparesis | Nausea Score Day 3 | 1.67 Patient Self-reported Symptom Score | Standard Error 1.49 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Nausea Associated With Gastroparesis | Nausea Score Day 7 | 1.4 Patient Self-reported Symptom Score | Standard Error 1.38 |
Primary
Symptom of Vomiting Associated With Gastroparesis
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Time frame: Study Day 0 (Baseline), Day 3, Day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Vomiting Associated With Gastroparesis | Vomiting Score Day 0 | 1.82 Patient Self-reported Symptom Score | Standard Error 1.55 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Vomiting Associated With Gastroparesis | Vomiting Score Day 3 | 0.17 Patient Self-reported Symptom Score | Standard Error 0.67 |
| Gastric Stimactivated Days1-4/Not Activated Days5-8 | Symptom of Vomiting Associated With Gastroparesis | Vomiting Score Day 7 | 0.91 Patient Self-reported Symptom Score | Standard Error 1.44 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Vomiting Associated With Gastroparesis | Vomiting Score Day 0 | 2.68 Patient Self-reported Symptom Score | Standard Error 1.61 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Vomiting Associated With Gastroparesis | Vomiting Score Day 3 | 1.20 Patient Self-reported Symptom Score | Standard Error 1.47 |
| Gastric StimulationNotActivated Days1-4/Activated Days5-8 | Symptom of Vomiting Associated With Gastroparesis | Vomiting Score Day 7 | 0.72 Patient Self-reported Symptom Score | Standard Error 1.17 |