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

NCT01916460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-06-02

No results posted yet for this study

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.

Conditions

  • Idiopathic Gastroparesis
  • Diabetic Gastroparesis

Interventions

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

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center, El Paso

    lead OTHER

Principal Investigators

  • Mohamed O Othman, MD · Texas Tech University Health Sciences Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01916460 on ClinicalTrials.gov