GI Neuromuscular Pathology Prospective Registry

NCT02165059 | Recruiting

• 1 other identifier: GI Neuromuscular Pathology
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroparesis

Keywords

Nausea; Vomiting; Functional dyspepsia; Bloating; Regurgitation; Retching

Outcome Measures

Primary Outcomes (1)

• Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes

  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

Study Arms (2)

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

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

Interventions

Surgical Full Thickness Biopsy PROCEDURE

Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.

Also known as: Biopsy, Surgical, Full-thickness, Stomach

GI Neuromuscal Disorder Cohort; GI Surgery Patients without neuromuscal disorders (control) cohort

Eligibility Criteria

• Age: 6 Months - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.
• 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

You may not qualify if:

• 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
• Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hosptial

Indianapolis, Indiana, 46202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Full thickness biopsies of Gastric body and proximal jejunum obtained.

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting; Gastroesophageal Reflux

Interventions

Biopsy; Surgical Procedures, Operative; Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• John M Wo, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Schilling

CONTACT

maschi@iu.edu

Lainna Cohen

CONTACT

larcohen@iu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 17, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-08

Locations

US (1)