Endoscopic Full Thickness Biopsy, Gastric Wall.

Mayo Clinic

Status: Completed

Conditions: Gastroparesis

Treatments: Procedure: Full thickness gastric biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01650714

12-000714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Full thickness gastric biopsy

Experimental group

Description:

Full thickness gastric biopsy

Treatment:

Procedure: Full thickness gastric biopsy

Procedure: Full thickness gastric biopsy