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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
Sponsor:
Information provided by (Responsible Party):
John M. Wo, Indiana University

Study Description
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Brief 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).

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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
Full thickness biopsies of Gastric body and proximal jejunum obtained.

Eligibility Criteria
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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
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Travis Putzke 317-278-2064 tputzke@iu.edu
Contact: Kara Murphy 317-278-0406 anigupta@iu.edu

Locations
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United States, Indiana
Indiana University Hosptial Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Travis Putzke    317-278-2064    tputzke@iu.edu   
Contact: Kara Murphy       clarkara@iu.edu   
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         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: John M Wo, MD Indiana University
More Information
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Additional Information:

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Responsible Party: John M. Wo, MD, Indiana University
ClinicalTrials.gov Identifier: NCT02165059    
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
Keywords provided by John M. Wo, Indiana University:
Nausea
Vomiting
Functional dyspepsia
 Bloating
Regurgitation
Retching
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations