Endoscopic Full Thickness Biopsy, Gastric Wall.

Endoscopic Full Thickness Biopsy of the Gastric Wall in Patients With Refractory Idiopathic Gastroparesis: Pilot Study to Detect Neuromuscular and Immune Pathologic Changes

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.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Other: Full thickness gastric biopsy; Procedure: Full thickness gastric biopsy

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Full thickness gastric biopsy	Other: Full thickness gastric biopsy; Procedure: Full thickness gastric biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with successful endoscopic full thickness gastric resection	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.	one week after surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (ESTIMATE): July 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 12-000714