GI Neuromuscular Pathology Prospective Registry
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|ClinicalTrials.gov Identifier: NCT02165059|
Recruitment Status : Recruiting
First Posted : June 17, 2014
Last Update Posted : February 14, 2022
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|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Indiana University GI Neuromuscular Pathology Prospective Registry|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Patients undergoing surgical full thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.
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.
- Clinical data at 4 time periods for study patents will be measured [ Time Frame: 2 years ]
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
- Positive Clinical Outcome to surgical implantation of GES measured by GCSI [ Time Frame: 6 months ]Responders will be defined as >50% improvement of the GCSI total score at 6 month after surgical GES
- Neuromuscular pathology results of the gastric body and proximal jejunum wil be compared between the following groups [ Time Frame: 6 months ]
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
- Correlation of Pathology Results and Questionnaire [ Time Frame: 6 months ]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.
Biospecimen Retention: Samples Without DNA
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|Ages Eligible for Study:||6 Months to 90 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165059
|Contact: Travis Putzkeemail@example.com|
|Contact: Kara Murphyfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University Hosptial||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Travis Putzke 317-278-2064 email@example.com|
|Contact: Kara Murphy firstname.lastname@example.org|
|Sub-Investigator: Tom V Nowak, MD|
|Sub-Investigator: Attila Nakeeb, MD|
|Sub-Investigator: Paul Herring, PhD|
|Sub-Investigator: Muhammad T Idress|
|Sub-Investigator: Chandrashekhar A Kubal, MD|
|Sub-Investigator: Jennifer Choi, MD|
|Sub-Investigator: Andrea Shin, MD/Fellow|
|Sub-Investigator: Anita Gupta, MBBS|
|Principal Investigator: JOhn M Wo, MD|
|Principal Investigator:||John M Wo, MD||Indiana University|
|Responsible Party:||John M. Wo, MD, Indiana University|
|Other Study ID Numbers:||
GI Neuromuscular Pathology
|First Posted:||June 17, 2014 Key Record Dates|
|Last Update Posted:||February 14, 2022|
|Last Verified:||February 2022|
Digestive System Diseases