Status:
COMPLETED
Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
Lead Sponsor:
Texas Tech University Health Sciences Center, El Paso
Conditions:
Idiopathic Gastroparesis
Diabetic Gastroparesis
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01916460
Start Date
March 1 2013
End Date
September 1 2014
Last Update
June 2 2021
Active Locations (1)
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1
Texas Tech University HSC at El Paso
El Paso, Texas, United States, 79912