Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01916460
Other study ID # E13052
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date September 2014

Study information

Verified date May 2021
Source Texas Tech University Health Sciences Center, El Paso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United States Texas Tech University HSC at El Paso El Paso Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Safety of EUS FNA of gastric wall ( wither perforation or tear developed after the procedure) The site of EUS FNA in the stomach wall will be examined surgically for perforations and tear during surgical placement of gastric neurostimulator within 24 hours
See also
  Status Clinical Trial Phase
Completed NCT01557296 - Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis Phase 2
Withdrawn NCT03376399 - Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms
Not yet recruiting NCT02264587 - Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis Phase 4
Completed NCT02289846 - Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP) Phase 2
Completed NCT03544229 - A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis Phase 2
Recruiting NCT04706832 - Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study N/A
Not yet recruiting NCT05584462 - Gastroparesis in type2 Diabetic Patient
Enrolling by invitation NCT05812339 - Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Completed NCT02732821 - G-POEM for Treatment of Refractory Gastroparesis
Completed NCT01030341 - Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis N/A
Recruiting NCT05832151 - A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis Phase 2
Completed NCT02025725 - Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis Phase 3
Completed NCT01469286 - Transcutaneous Electroacupuncture for Gastroparesis Phase 1
Terminated NCT00874133 - The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis N/A
Completed NCT01126034 - Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention N/A
Recruiting NCT05273788 - Thoracic Neuromodulation for Diabetic Gastroparesis N/A
Suspended NCT00470795 - Acupuncture for Diabetic Gastroparesis Phase 3
Completed NCT00139893 - A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis N/A
Recruiting NCT04254549 - Rifaximin in Patients With Diabetic Gastroparesis Phase 2
Not yet recruiting NCT04661215 - Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms