NCT00455078

GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

The Role of Reflux in Innate Immunity Activation After Lung Transplantation.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
PROCEDURE	esophagogastroduodenoscopy	EGD will be done pretransplant then again before 18mos post transplant.
OTHER	Standard GER questionnaire (RDQ)	RDQ questionnaire will be done pretransplant then again before 18mos post transplant.
PROCEDURE	Scintigraphic evaluation of solid gastric emptying	Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.
PROCEDURE	Twenty-four hour ambulatory pH testing	Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.
PROCEDURE	Esophageal manometry testing	Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-04-03
• Last updated: 2013-09-05

Locations

1 site across 1 country: United States