GI Neuromuscular Pathology Prospective Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Indiana University GI Neuromuscular Pathology Prospective Registry

Conditions
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Gastroparesis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Patients undergoing surgical full thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder. | |
| Control Group<br>Patient undergoing esophagectomy, sleeve gastrectomy for obesity, Roux-en-Y gastric bypass, Whipple surgery, transplant surgery. Patients who are organ donors and undergoing surgery are also part of the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data at 4 time periods for study patents will be measured | Follow up clinical data will be obtained before, 6 months, 1.5 years, and 2 years after the full thickness biopsy. Follow up clinical data PAGI-SYM Overall Treatment Effect by Patient Overall Treatment Effect by Physician | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Clinical Outcome to surgical implantation of GES measured by GCSI | Responders will be defined as >50% improvement of the GCSI total score at 6 month after surgical GES | 6 months | 
| Neuromuscular pathology results of the gastric body and proximal jejunum wil be compared between the following groups | Patients with gastroparesis from type 1 DM versus patients with idiopathic gastroparesis. Patients with gastroparesis from type I DM versus gastroparesis from type 2 DM | 6 months | 
| Correlation of Pathology Results and Questionnaire | Neuromuscular pathology results of the gastric body and proximal jejunum will be correlated with the following: Symptom severity (GCSI total score), predominant symptom presentation, severity of delayed gastric emptying. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retching, Nausea, Vomiting, Functional dyspepsia, Bloating, Regurgitation