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Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients

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ClinicalTrials.gov Identifier: NCT01916460
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center, El Paso

June 23, 2013
August 5, 2013
July 26, 2016
March 2013
September 2014   (Final data collection date for primary outcome measure)
The ability of EUS FNA needle to obtain gastric smooth muscle tissue [ Time Frame: During the procedure ( 45 minutes) ]
Wither FNA needle can obtain sufficient muscularis propria tissue from the gastric wall to perform histological staining for the interstitial cell of Cajal and smooth muscles markers. The specimen from the FNA needle will be compared to the standard full thickness gastric biopsy which is routinely obtained in our institution during the surgical placement of the gastric stimulator.
Same as current
Complete list of historical versions of study NCT01916460 on ClinicalTrials.gov Archive Site
Safety of EUS FNA of gastric wall ( wither perforation or tear developed after the procedure) [ Time Frame: within 24 hours ]
The site of EUS FNA in the stomach wall will be examined surgically for perforations and tear during surgical placement of gastric neurostimulator
Same as current
Not Provided
Not Provided
 
Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
Not Provided

Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. The loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to now, the only way to obtain a tissue sample from the stomach muscle was to undergo an operation in the surgery suite and be hospitalized for several days after the procedure. Usually, we obtain this sample while these patients are having a surgery for another purpose such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound is an endoscope (a tube with a source of light and ultrasound installed in the tip of the tube) that can measure how thick the stomach wall is and can provide sample "biopsies" of the stomach wall which can be studied for the loss of these specialized muscles and cells.

We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to diagnose "gastroparesis" and can replace the need for obtaining samples by surgery. Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Idiopathic Gastroparesis
  • Diabetic Gastroparesis
  • Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
    After the subjects meet the criteria for enrollment in the study, gastroparetic patients will undergo linear EUS examination of the stomach wall one day prior to their surgery to obtain single or multiple core biopsies of the stomach body wall using the 19-gauge core biopsy needle under EUS guidance. The pathologist will be in the room to assess the adequacy of the sample after each pass. Once the pathologist deemed that the obtained sample is sufficient, the procedure will be terminated
  • Device: 19 guage fine needle aspiration needle
Experimental: Gastroparetic patient
EUS FNA of the gastric wall prior to surgical placement of gastric neurostimulator
Interventions:
  • Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
  • Device: 19 guage fine needle aspiration needle
Othman MO, Davis B, Saroseik I, Torabi A, McCallum RW. EUS-guided FNA biopsy of the muscularis propria of the antrum in patients with gastroparesis is feasible and safe. Gastrointest Endosc. 2016 Feb;83(2):327-33. doi: 10.1016/j.gie.2015.06.056. Epub 2015 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
10
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients (age 18 to 80) with objective evidence of gastroparesis who will undergo surgical placement of gastric pacemaker and full thickness gastric wall biopsy. Objective evidence of gastroparesis include the following:

    1. Documented symptoms of gastroparesis for longer than 6 months.
    2. More than 7 episodes of vomiting per week
    3. Refractoriness or intolerance to antiemetics and prokinetic medications
    4. Delayed gastric emptying of solid meal (>60% gastric retention at 2 hours and >10% at 4 hours postprandial) using a standard 4-hour scintigraphic method

Exclusion Criteria:

  • Patients with documented organic or intestinal pseudo-obstruction , primary eating or swallowing disorders, rumination syndrome, psychogenic vomiting, cyclic vomiting syndrome, systemic sclerosis, thyroid and adrenal disease, chemical dependency, cancer, peritoneal dialysis, pregnancy.Also, patients with history of gastric surgery such as partial gastric resection or vagatomy.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01916460
E13052
Yes
Not Provided
Not Provided
Texas Tech University Health Sciences Center, El Paso
Texas Tech University Health Sciences Center, El Paso
Not Provided
Not Provided
Texas Tech University Health Sciences Center, El Paso
July 2016

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