Endoscopic Full Thickness Biopsy, Gastric Wall.

Our group has studied a new endoscopic method using a submucosal endoscopy with mucosal flap
(SEMF) technique to acquire full thickness gastric tissues successfully and safely in
preclinical studies.

The proposed study will assess the efficacy and safety of the innovative endoscopic
technique for the acquisition of full thickness gastric muscle wall biopsies. Having access
to full thickness biopsies will allow an increased understanding of the pathophysiology of
gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,
pseudoobstruction and other motility disorders. This information is essential to
development of more targeted and effective therapy than currently available. Despite the
high prevalence of functional gastrointestinal disorders and its significant impact on
social and health care costs, the underlying cause is not well understood and there is no
effective specific treatment to successfully alleviate patient symptoms.

Inclusion Criteria:

1. Symptomatic refractory idiopathic gastroparesis:

1. The refractory nature of symptoms (e.g. based on nutritional failure,
consideration for enteral or parenteral nutrition) will be determined by the
physician/gastroenterologist who is the primary care provider for the patient's
gastroparesis.

2. Patients will have documentation within the last 2 years of delayed gastric
emptying with >30% retained gastric contents at 4 hours based on 296 kcal
solid-liquid, fat-containing standard meal gastric emptying test.

3. The patient's physician will determine if this procedure may potentially provide
prognostic and therapeutic options.

2. Age > 18 and < 70 years old

3. Hemoglobin (Hb) > 10g, platelets >150,000 and prothrombin time- international
normalized ratio (INR) <1.5

4. Ability to give informed consent

Exclusion Criteria:

1. Prior oropharyngeal, esophageal, gastric or small bowel surgery

2. Esophageal stricture

3. Prior abdominal radiation therapy

4. Prior feeding tube placement

5. Coagulopathy

6. Use of Coumadin or anti-platelet drugs e.g. Plavix, steroids or
immunosuppressive drugs

7. Pregnancy -