GI Neuromuscular Pathology Prospective Registry

Recruiting

• Conditions: Gastroparesis
• Interventions: Procedure: Surgical Full Thickness Biopsy

• Registration Number: NCT02165059
• Lead Sponsor: Indiana University

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes	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.

Trial Locations

Locations (1)

Indiana University Hosptial; 🇺🇸 Indianapolis, Indiana, United States