Clinical trial NCT02165059: GI Neuromuscular Pathology Prospective Registry
Official title: Indiana University GI Neuromuscular Pathology Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Keywords: Nausea
Vomiting
Functional dyspepsia
Bloating
Regurgitation
Retching
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with gastropareiss and are undergoing surgery for full thickness biopsy GES implantation willl serve as our study group, Patients who are undergoing surgery on the digestive system but do not have gastroparesis, will serve as our control group.

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.

Eligibility criteria: 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

Exclusion Criteria Control Group:

Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor

Primary outcomes:
measure: Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes
timeFrame: from implantation to 6 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hosptial
state: Indiana
Study officials:
affiliation: Indiana University
name: John M Wo, MD
role: PRINCIPAL_INVESTIGATOR
References: