Registry for understanding gastroparesis and related motility disorders
Indiana University GI Neuromuscular Pathology Prospective Registry
This study is trying to understand the causes of gastroparesis and related digestive issues by collecting samples and information from patients having surgery for these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 6 Months to 90 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT02165059 on ClinicalTrials.gov |
What this trial studies
This observational study collects biopsy samples from patients diagnosed with gastroparesis who are undergoing gastric electrical stimulation implantation surgery. It also includes a control group of patients without gastroparesis undergoing various digestive surgeries. The study aims to investigate the underlying causes of motility disorders, assess symptom severity through questionnaires, and follow patients over 24 months to evaluate outcomes. The collected data will help direct future investigations and improve prognosis for patients with these conditions.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with gastroparesis who are scheduled for surgical biopsy and those undergoing specific digestive surgeries without gastroparesis.
Not a fit: Patients with significant comorbidities, contraindications for biopsy, or prior diagnoses of gastroparesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of gastroparesis, improving treatment options for patients.
How similar studies have performed: While similar studies have explored motility disorders, this specific registry approach focusing on biopsy samples is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University Hosptial — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: John M Wo, MD — Indiana University
- Study coordinator: Maureen Schilling
- Email: maschi@iu.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.