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

NCT01916460 | Completed DMC

• 1 other identifier: E13052
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastroparesis; Endoscopic ultrasound; Interstitial cell of Cajal

Outcome Measures

Primary Outcomes (1)

• The ability of EUS FNA needle to obtain gastric smooth muscle tissue

  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.

  During the procedure ( 45 minutes)

Secondary Outcomes (1)

• Safety of EUS FNA of gastric wall ( wither perforation or tear developed after the procedure)

  within 24 hours

Study Arms (1)

Gastroparetic patient 19G

EXPERIMENTAL

Endoscopic Ultrasound Fine Needle Aspiration of the gastric wall prior to surgical placement of gastric neurostimulator with 19-gauge fine core needle used for aspiration

Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)

Interventions

Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) PROCEDURE

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

Gastroparetic patient 19G

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Documented symptoms of gastroparesis for longer than 6 months.
• More than 7 episodes of vomiting per week
• Refractoriness or intolerance to antiemetics and prokinetic medications
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University HSC at El Paso

El Paso, Texas, 79912, United States

Location

Related Publications (1)

• 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.

  PMID: 26318833 DERIVED

MeSH Terms

Conditions

Gastroparesis

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Mohamed O Othman, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2013
• First Posted: August 5, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)