Clinical trial NCT00455078: GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection
Official title: The Role of Reflux in Innate Immunity Activation After Lung Transplantation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: Gastric reflux
Lung transplant
chronic rejection
Gastric reflux in lung transplant as it relates to chronic rejection
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone pretransplant evaluation and are on the waiting list or subjects transplanted \< 18mos.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Sangeeta M. Bhorade, MD
role: PRINCIPAL_INVESTIGATOR
References: