GI Neuromuscular Pathology Prospective Registry

Gastroparesis Clinical Trial

Official title:

Indiana University GI Neuromuscular Pathology Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02165059
• Other study ID #: GI Neuromuscular Pathology
• Status: Recruiting
• Start date: December 2013
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: Indiana University
• Contact: Travis Putzke
• Phone: 317-278-2064
• Email: tputzke[@]iu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
United States	Indiana University Hosptial	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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