Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/14/2017 |
| Start Date: | March 2013 |
| End Date: | September 2014 |
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.
"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.
Inclusion Criteria:
- 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:
1. Documented symptoms of gastroparesis for longer than 6 months.
2. More than 7 episodes of vomiting per week
3. Refractoriness or intolerance to antiemetics and prokinetic medications
4. 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
Exclusion Criteria:
- 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.
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