RecruitingNCT02165059

GI Neuromuscular Pathology Prospective Registry

Indiana University GI Neuromuscular Pathology Prospective Registry


Sponsor

Indiana University

Enrollment

300 participants

Start Date

Dec 1, 2013

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 6 MonthsMax Age: 90 Years

Inclusion Criteria3

  • Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.
  • 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 Criteria3

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

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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.


Locations(1)

Indiana University Hosptial

Indianapolis, Indiana, United States

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NCT02165059


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