GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection (LTXGERD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00455078|
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : September 5, 2013
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.
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux||Procedure: esophagogastroduodenoscopy Other: Standard GER questionnaire (RDQ) Procedure: Scintigraphic evaluation of solid gastric emptying Procedure: Twenty-four hour ambulatory pH testing Procedure: Esophageal manometry testing|
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.
- Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.
- Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.
- Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.
- 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.
- 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 Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||The Role of Reflux in Innate Immunity Activation After Lung Transplantation.|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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): NCT00455078
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Sangeeta M. Bhorade, MD||University of Chicago|