Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
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, GI symptoms will decrease by at least 50% from baseline.
Gastric Electrical Stimulation (GES) is an established treatment for drug-refractory patients who have the symptoms of gastroparesis/gastropathy (GP). 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 UT-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 GES 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 GES electrode in the stomach with an upper endoscope, combined with an external GES 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 (TempStim), 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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Gastric Electrical Stimulator
University of Mississippi Medical Center
Active, not recruiting
University of Mississippi Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00432835
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Chronic delayed gastric emptying. Gastroparesis may be caused by motor dysfunction or paralysis of STOMACH muscles or may be associated with other systemic diseases such as DIABETES MELLITUS.
Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.
A gastrointestinal peptide hormone of about 43-amino acids. It is found to be a potent stimulator of INSULIN secretion and a relatively poor inhibitor of GASTRIC ACID secretion.
Neuroendocrine cells in the glands of the GASTRIC MUCOSA. They produce HISTAMINE and peptides such as CHROMOGRANINS. ECL cells respond to GASTRIN by releasing histamine which acts as a paracrine stimulator of the release of HYDROCHLORIC ACID from the GASTRIC PARIETAL CELLS.
Vagal denervation of that part of the STOMACH lined with acid-secreting mucosa (GASTRIC MUCOSA) containing the GASTRIC PARIETAL CELLS. Since the procedure leaves the vagal branches to the antrum and PYLORUS intact, it circumvents gastric drainage required with truncal vagotomy techniques.
This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device....
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gast...
Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach.T...
The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients
Gastroparesis is an entity of symptomatic abnormal gastric emptying, with diabetes mellitus, postsurgical and idiopathic etiologies accounting for majority of the cases.
To improve the therapeutic effects of gastric electrical stimulation (GES) for obesity, an animal experiment was conducted using a new type of stimulators. Proper parameters of GES were selected, and...
The objective of this work was to perform an open trial of the effects of nizatidine (NZT), a selective histamine H2-receptor antagonist and a cholinomimetic, on gastroparesis in Parkinson's disease (...
A patient with gastroparesis is presented. Ultimately the diagnosis of paraneoplastic gastroparesis due to an occult small cell cancer of the lung was made. The difficulties in the diagnostic process...
The relationship between time-courses of mechanical and electrical events in longstanding diabetes was investigated in rats. Magnetic markers and electrodes were surgically implanted in the gastric se...