Clinical trial NCT01650714: Endoscopic Full Thickness Biopsy, Gastric Wall.
Official title: Endoscopic Full Thickness Biopsy of the Gastric Wall in Patients With Refractory Idiopathic Gastroparesis: Pilot Study to Detect Neuromuscular and Immune Pathologic Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Number of patients with successful endoscopic full thickness gastric resection
timeFrame: one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elizabeth Rajan, MD
role: PRINCIPAL_INVESTIGATOR
References: