Endoscopic Full Thickness Biopsy, Gastric Wall.

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.
Age > 18 and < 70 years old
Hemoglobin (Hb) > 10g, platelets >150,000 and prothrombin time- international normalized ratio (INR) <1.5
Ability to give informed consent

Exclusion Criteria

Prior oropharyngeal, esophageal, gastric or small bowel surgery
Esophageal stricture
Prior abdominal radiation therapy
Prior feeding tube placement
Coagulopathy
Use of Coumadin or anti-platelet drugs e.g. Plavix, steroids or immunosuppressive drugs
Pregnancy -

Arm && Interventions

Group	Intervention	Description
Full thickness gastric biopsy	Full thickness gastric biopsy	Full thickness gastric biopsy

Primary Outcome Measures

Name	Time	Method
Number of patients with successful endoscopic full thickness gastric resection	one week after surgery	Success of the endoscopic resection will be defined by efficacy and safety: 1) Efficacy is defined as obtaining a full thickness resection and 2) Safety is defined as the absence of serious adverse events.

Secondary Outcome Measures

Name	Time	Method

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