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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01916460
First received: June 23, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Idiopathic Gastroparesis
Diabetic Gastroparesis
Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Device: 19 guage fine needle aspiration needle

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • The ability of EUS FNA needle to obtain gastric smooth muscle tissue [ Time Frame: During the procedure ( 45 minutes) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety of EUS FNA of gastric wall ( wither perforation or tear developed after the procedure) [ Time Frame: within 24 hours ] [ Designated as safety issue: Yes ]
    The site of EUS FNA in the stomach wall will be examined surgically for perforations and tear during surgical placement of gastric neurostimulator


Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastroparetic patient
EUS FNA of the gastric wall prior to surgical placement of gastric neurostimulator
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 gastroparesisincludethe 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916460

Contacts
Contact: Mohamed O Othman, MD 915.545.6618 mohamed.othman@ttuhsc.edu
Contact: Richard McCallum, MD 915.545.6618 Richard.mccallum@ttuhsc.edu

Locations
United States, Texas
Texas Tech University HSC at El Paso Recruiting
El Paso, Texas, United States, 79912
Contact: Mohamed O Othman, MD    915-545-6618    mohamed.othman@ttuhsc.edu   
Principal Investigator: Mohamed O Othman, MD         
Principal Investigator: Richard M McCallum, MD         
Sub-Investigator: Irene Sarosiek, MD         
Principal Investigator: Brian Davis, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01916460     History of Changes
Other Study ID Numbers: E13052
Study First Received: June 23, 2013
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Gastroparesis
Endoscopic ultrasound
Interstitial cell of Cajal

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

ClinicalTrials.gov processed this record on October 19, 2014