Gastroparesis
Conditions
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.
Interventions
OTHERFull thickness gastric biopsy
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed