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Endoscopic Full Thickness Biopsy, Gastric Wall.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Rajan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01650714
First received: July 24, 2012
Last updated: January 9, 2014
Last verified: January 2014

July 24, 2012
January 9, 2014
September 2012
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01650714 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Gastroparesis
  • Other: Full thickness gastric biopsy
  • Procedure: Full thickness gastric biopsy
Experimental: Full thickness gastric biopsy
Full thickness gastric biopsy
Interventions:
  • Other: Full thickness gastric biopsy
  • Procedure: Full thickness gastric biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3
September 2014
June 2014   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01650714
12-000714
Yes
Elizabeth Rajan, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Elizabeth Rajan, MD Mayo Clinic
Mayo Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP