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Endoscopic Full Thickness Biopsy, Gastric Wall.

This study is currently recruiting participants.
Verified February 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Elizabeth Rajan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01650714
First received: July 24, 2012
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Gastroparesis
 Other: Full thickness gastric biopsy
Procedure: Full thickness gastric biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of patients with successful endoscopic full thickness gastric resection [ Time Frame: one week after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 3
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full thickness gastric biopsy
Full thickness gastric biopsy
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650714

Contacts
Contact: Elizabeth Rajan, MD 507-507-266-3848 rajan.elizabeth16@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Elizabeth Rajan, MD     507-266-3972     rajan.elizabeth16@mayo.edu    
Contact: Mary A Knipschield     507-266-3972     knipschield.mary@mayo.edu    
Principal Investigator: Elizabeth Rajan, MD            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Elizabeth Rajan, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Elizabeth Rajan, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01650714     History of Changes
Other Study ID Numbers: 12-000714
Study First Received: July 24, 2012
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013