Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
Completed · Not applicable
Conditions studied: Idiopathic Gastroparesis, Diabetic Gastroparesis
In brief
Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. The loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to now, the only way to obtain a tissue sample from the stomach muscle was to undergo an operation in the surgery suite and be hospitalized for several days after the procedure. Usually, we obtain this sample while these patients are having a surgery for another purpose such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound is an endoscope (a tube with a source of light and ultrasound installed in the tip of the tube) that can measure how thick the stomach wall is and can provide sample "biopsies" of the stomach wall which can be studied for the loss of these specialized muscles and cells. We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to diagnose "gastroparesis" and can replace the need for obtaining samples by surgery. Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.
Key facts
- Study ID
- NCT01916460
- Run by
- Texas Tech University Health Sciences Center, El Paso
- People needed
- 11
- Starts
- 2013-03-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2021-06-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients (age 18 to 80) with objective evidence of gastroparesis who will undergo surgical placement of gastric pacemaker and full thickness gastric wall biopsy. Objective evidence of gastroparesis include the following:
- Documented symptoms of gastroparesis for longer than 6 months.
- More than 7 episodes of vomiting per week
- Refractoriness or intolerance to antiemetics and prokinetic medications
- Delayed gastric emptying of solid meal (>60% gastric retention at 2 hours and >10% at 4 hours postprandial) using a standard 4-hour scintigraphic method
You may not qualify if…
- Patients with documented organic or intestinal pseudo-obstruction , primary eating or swallowing disorders, rumination syndrome, psychogenic vomiting, cyclic vomiting syndrome, systemic sclerosis, thyroid and adrenal disease, chemical dependency, cancer, peritoneal dialysis, pregnancy.Also, patients with history of gastric surgery such as partial gastric resection or vagatomy.
Where it is running
- Texas Tech University HSC at El Paso — El Paso, Texas, United States
Full record on ClinicalTrials.gov
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