GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

Completed

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT00455078
• Lead Sponsor: University of Chicago

Brief Summary

Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation.

The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune system and cause CR. In this way, we would be able to better identify patients that may benefit from anti-reflux procedures.

Detailed Description

Part of standard pre-transplant work up includes a gastrointestinal (GI) work-up to check for GER. The following procedures will be done pre-transplant.

1. Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.

2. Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.

3. Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.

4. Twenty-four hour ambulatory pH testing: The ambulatory 24-hour pH monitoring test will monitor the acid in the esophagus during a 24-hour period.

5. Esophageal manometry testing: This procedure is done to evaluate the cause of reflux of stomach acid and contents back into the esophagus, and to determine the cause of problems with swallowing food.

These procedures will be done again at 3 to 6 months post transplant. The results of the EGD, scintigraphic evaluation, answers of RDQ, pH testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection.

Study Timeline

• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Study First Posted: 2007-04-03
• Study Start: 2007-06
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who are undergoing pre-lung transplant evaluations at the University of Chicago Hospital
• Patients who are capable of becoming pregnant must have a negative pregnancy test prior to consent.
• All patients must be able to give written informed consent.

Exclusion Criteria

• Pre-transplant patients in whom study procedures are contraindicated or patients who are unable to complete all the study procedures.
• Patients who are unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States