Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
Condition: Idiopathic Gastroparesis; Diabetic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      EUS Fine Needle Aspiration (FNA) Biopsies of the Muscularis Propria (MP) of the gastric wall
      in patients with gastroparesis (GP) could replace the routine use of surgical full thickness
      biopsies (FTB) for assessing loss of Interstitial Cell of Cajal (ICC) and cellular
      infiltrates in the myenteric plexus. The principal investigator investigated the efficacy and
      safety of EUS Fine Needle Aspiration biopsies of the Muscularis Propria of the stomach antrum
      in gastroparesis and compared the tissue to a surgically obtained full thickness biopsies in
      the same patient.

      This was a prospective, nonrandomized, feasibility trial. Patients with gastroparesis who
      were undergoing gastric neurostimulator placement were enrolled. Patients had a gastric wall
      measurement by radial EUS in the body and antrum of the stomach followed by linear EUS
      examination and FNA of the muscularis propria in the antrum by using a 19-gauge core needle.
      Within 24 hours, a full-thickness biopsy specimen of the antrum was obtained surgically
      during neurostimulator placement. Endoscopic and surgical specimens were compared for tissue
      morphology, number of ICCs (c-kit stain) and enteric neurons (S-100 stain), and fibrosis
      (trichome) for each patient. The correlation coefficient of the ICC count per high-power
      field was used to compare both specimens. Continuous data were compared by using a t test.
    

Intervention name(s): Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Intervention type(s): Procedure
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gastroparesis; Endoscopic ultrasound; Interstitial cell of Cajal