GI Neuromuscular Pathology Prospective Registry

October 4, 2024 updated by: John M. Wo, Indiana University

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

Intervention / Treatment

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 (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Hosptial
        • Contact:
        • Contact:
        • Contact:
          • Tom V Nowak, MD
        • Contact:
          • Attila Nakeeb, MD
        • Contact:
          • Paul Herring, PhD
        • Contact:
          • Muhammad T Idress
        • Contact:
          • Chandrashekhar A Kubal, MD
        • Contact:
          • Jennifer Choi, MD
        • Contact:
          • John M Wo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GI Neuromuscal Disorder Cohort
Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder
Procedure: Surgical 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.
Other Names:
  • Surgical
  • Biopsy
  • Full-thickness
  • Stomach
GI Surgery Patients without neuromuscal disorders (control) cohort
Patients undergoing esophagectomy, sleeve gastrectomy for obesity, Roux-en-Y gastric bypass, whipple surgery, transplant surgery, or organ donors.
Procedure: Surgical 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.
Other Names:
  • Surgical
  • Biopsy
  • Full-thickness
  • Stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes
Time Frame: from implantation to 6 months after
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 gastric electrical stimulation (GES) for severe gastroparesis.
from implantation to 6 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimated)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI Neuromuscular Pathology

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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