Gastroparesis
Conditions
Keywords
Nausea, Vomiting, Functional dyspepsia, Bloating, Regurgitation, Retching
Brief summary
In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).
Detailed description
Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation.
Interventions
PROCEDURESurgical Full Thickness Biopsy
Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.
Sponsors
Indiana University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Study Group: Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder. Inclusion Criteria Control Group: Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery Patients who are organ donors and undergoing surgery
Exclusion criteria
Study Group: Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease. Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes | from implantation to 6 months after | To determine if ICC abnormalities of the stomach and proximal jejunum can be used as a biologic marker in predicting clinical outcome in patients undergoing surgical implantation of gastric electrical stimulation (GES) for severe gastroparesis. |
Countries
United States
Contacts
CONTACTMaureen M Schilling, MD
CONTACTJohn Wo
PRINCIPAL_INVESTIGATORJohn M Wo, MD
Indiana University
Outcome results
None listed