Indiana University GI Neuromuscular Pathology Prospective Registry

J
John Wo, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

What is the purpose of this study?
The purpose of this study is 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 GES for severe gastroparesis. The primary aim is 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 GES for severe gastroparesis. Patients who are undergoing surgical full thickness biopsy of the stomach and /or proximal jejunum will be included in the study. These subjects have gastroparesis and will be part of our treatment group or study subject group. Patients who are undergoing full thickness biopsy of the stomach and /or jejunum as part of esophagectomy, sleeve gastrectomy for obesity, Roux-en-Y gastric bypass or Whipple surgery at University Hospital and IU North Hospital will be part of the control group.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients for treatment group will be identified from the clinics of the principal and sub investigators that may/will be potential subjects for undergoing a GES implantation procedure for gastroparesis. The subjects for the control group will be identified from the clinics of the principal and sub- investigators who will be undergoing a gastrointestinal surgical procedure like Whipples surgery, esophagectomy, sleeve gastrectomy for obesity, or Roux-en-Y gastric bypass under standard of clinical care. The control group subjects will also be identified from the clinics of the sub-investigators who are potential organ donors and are ready to donate their organs. The PI and SubI will also be conducting a retrospective review of existing data based on full thickness biopsy slides that were previously stored.

Detailed description of study

What will happen during the study?
This study will be conducted at University Hospital, IU Health North hospital and Riley Hospital.
 • The subject will be asked about their medical history including onset of symptoms and diagnosis.
 • They will be asked to complete 2 questionnaires in person or online using RedCap that will assess the severity of their symptoms and also the type of symptoms that have had at baseline.
 • As part of standard procedure surgery will be performed depending on the diagnoses and a full thickness biopsy of the stomach and / or upper small intestine (proximal jejunum) will be obtained. The specimen will be divided in multiple parts, one part will be sent to pathology lab for standard reading, while the other parts will be sent to the research lab for biochemical analysis. Personal health information will also be collected about the subject. This personal health information will be obtained from their medical record and may be updated when the health information is updated at the doctor visits.
 • If the subject is in the treatment group( have had GES implantation), then will be followed-up in clinic. Timing will be at the discretion of the PI or the Sub-I after implantation.
 • They will be asked to fill out 2 questionnaires in person or online using RedCap at each of the follow up visits in clinic.
 • If the subject is in the control group (have not been diagnosed with gastroparesis and not had a GES implanted), then your follow-up clinical data will be obtained before and after the full thickness biopsy at the discretion of the PI and the SubI. The subjects will not be followed up in the clinic by the investigator.
 • If during the course of the study the subject is undergoing a procedure as given above where biopsy is being taken for standard of care, then part of that biopsy may be taken for research for this study, including vagal nerve biopsies from organ donors (control subjects), whenever feasible.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gastroparesis, GI Neuromuscular Disorder
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria for Study Subject i. Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder. V. Inclusion Criteria for Control Subject i. Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en-Y gastric bypass at University Hospital and IU North Hospital (gastric full-thickness specimen). ii. Patients undergoing Whipple surgery at University Hospital, Riley Hospital, which routinely includes removing the first 6 inches of jejunum as part of the procedure (proximal jejunum full-thickness specimen). iii. Patients who are undergoing transplant surgery at University Hospital, Riley Hospital. iv. Patients who are organ donors from the transplant program at University Hospital, Riley Hospital

 

Exclusion Criteria for Study Subject i. Contraindication for surgical full-thickness biopsy for any reason. ii. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease. iii. Significant coagulopathy iv. Non-ambulatory patients: bed-ridden, nursing home resident, etc. v. Pregnant vi. Unable to give own informed consent vii. Prisoners Exclusion Criteria for Control Subject i. Prior diagnosis of gastroparesis ii. Prior diagnosis of chronic intestinal pseudo-obstruction iii. Significant coagulopathy iv. Pregnant v. Unable to give own informed consent if not an organ donor vi. Prisoners

Updated on 28 Apr 2025. Study ID: GI-IIR-WO-PATHREG, 1309147354
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only