GI Neuromuscular Pathology Prospective Registry

Indiana University GI Neuromuscular Pathology Prospective Registry

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).

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Travis Putzke; Phone Number: 317-278-2064; Email: tputzke@iu.edu
• Study Contact Backup: Name: Kara Murphy; Phone Number: 317-278-0406; Email: anigupta@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Hosptial
      • Contact: Travis Putzke; Phone Number: 317-278-2064; Email: tputzke@iu.edu
      • Principal Investigator: JOhn M Wo, MD
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with gastropareiss and are undergoing surgery for full thickness biopsy GES implantation willl serve as our study group, Patients who are undergoing surgery on the digestive system but do not have gastroparesis, will serve as our control group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study Group; Patients undergoing surgical full thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.
Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: John M Wo, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Regurgitation; Bloating; Functional dyspepsia; Retching
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: GI Neuromuscular Pathology