Endoscopic Full Thickness Biopsy, Gastric Wall.

Completed · Not applicable

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT01650714

Run by

Mayo Clinic

People needed

3

Starts

2012-09-01

Expected to finish

2014-09-01

Last updated by the study team

2015-05-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic refractory idiopathic gastroparesis:
• 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.
• 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.
• 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

You may not qualify if…

• 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 -

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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