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Endoscopic Full Thickness Biopsy, Gastric Wall.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650714
First Posted: July 26, 2012
Last Update Posted: May 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth Rajan, Mayo Clinic
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Elizabeth Rajan, Mayo Clinic:

Primary Outcome Measures:
  • Number of patients with successful endoscopic full thickness gastric resection [ Time Frame: one week after surgery ]
    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.


Enrollment: 3
Study Start Date: September 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650714


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Elizabeth Rajan, MD Mayo Clinic
  More Information

Responsible Party: Elizabeth Rajan, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01650714     History of Changes
Other Study ID Numbers: 12-000714
First Submitted: July 24, 2012
First Posted: July 26, 2012
Last Update Posted: May 14, 2015
Last Verified: May 2015

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